Swift Portable:
Contents
1. a 55 mS gt 2 HS 4 E 1 e M n UH am i e 9 de mE IBN Ta Order Call 1 800 884 3907 Group 6 Large areas devoid of cementum were seen at magnifications of 70 Fig 5A These were seen in all teeth and on almost all test surfaces Denuded dentinal tubuli were only occasionally seen in the treated areas In some areas the cemen tum seemed to have split off or been torn from the root surface A clear demarcation zone with an irregular contour bordering the control areas was evident Fig 5B Amplitude measurements The numeric values of the amplitude measurements are summarized in Table 1 Amdent tips showed only longitudinal movements The other instruments had both longi tudinal and transversal patterns of movement which were most pronounced for the Titan S tip Discussion The experimental procedure in this in vitro study was designed to mimic scaling in a clinical setting as much as possible For comparison between in struments the number of strokes was standardized The objective was to cover the selected test surface without unnecessary overlapping Consequently the whole surface showed the effect of one or at the most two strokes Since loss of tooth substance was not included in the study the different stroke design 10 pull strokes for curettes and 10 back 5B 222. 2 CARBAMIDE PEROXIDE BLEACHING TECHNIQUE FOR SINGLE TOOTH DEMONSTRATED Chong Y H Quint Int 1993 24 233 235 Bleaching vital teeth outside dental office using carbamide peroxide is well known amp widely accepted especially for removal of brown orange or yellow hues However most practitioners have noti considered use for only one or a few discolored teeth Author describes successful bleaching one central incisor by making conventional nightguard splint for entire arch but placing bleach gel only in nightguard space where darkened tooth was located Opalescence Ultradent Products was used for 4 weeks 8 hours per night IS THERE ROOM IN DENTAL PRODUCT MARKETPLACE FOR SHOPPING SERVICES Publication of advantages amp disadvantages of national shopping service has resulted in unprecedented praise amp criticism Feb 93 CRA Newsletter report on Profitfinder Evaluation of shopping services was initiated in spring 92 in response to requests from clinicians Goals of evaluation were to confirm claims ascertain if membership fees were justified amp determine clinical usefulness of national shopping for dental products Results showed national shopping very informative in gaining national perspective on product costs Profitfinder was most highly rated of shopping services evaluated because it 1 allowed any dealer to participate 2 dissociated Profitfinder from transaction between dentist amp dealer by m
3. Jonsson WIEN IRAUB HAMMARSTR M L New attachment in monkeys with experimental periodontitis with and without removal of the cementum J Clin Periodontol 1987 14 136 43 BORN LINDHE J The influence of periodontal instru ments on the tooth surface A methodological study Odon tol Rev 1962 13 355 69 Kerry GJ Roughness of root surfaces after use of ultra sonic instruments and hand curettes J Periodontol 1967 38 340 6 Wirxinson RF JE Scanning electron micro scopy of the root surface following instrumentation J Peri odontol 1973 44 559 63 33 Meyer K LIE T Root surface roughness in response to periodontal instrumentation studied by combined use of microroughness measurements and scanning electron microscopy J Clin Periodontol 1977 4 77 9 Hunter RK O Leary TJ Karrawy The effectiveness of hand versus ultrasonic instrumentation in open flap root planing J Periodontal 1984 55 697 702 DEI AMERICA CORP IN THIS ISSUE ULTRASONIC amp SONIC SCALERS pages 1 3 9 NOTE ON PROFITFINDER page 4 VOLUME 17 1550 4 APRIL 1993 17TH YEAR OF PUBLICATION DEDICATED TO SERVING DENTISTRY Clinical Research Associates 3707 NORTH CANYON ROAD SUITE 6 Newsletter SUBJECT ULTRASONIC amp SONIC SCALERS There are many ultrasonic amp sonic scaling instruments available today Pertinent clinical questions are 1 What are ultra
4. Swift Portable The Perfect Combination DEI AMERICA CORP Helping Create Beautiful Smiles Information Booklet gt gt gt Introduction Benefits Technical Data Certification amp Approvals Accessories Page 7 To Order Call 1 800 884 3507 e About DBI America Corp Dental Business International D B 1 is a privately owned company with over twenty five years of Dental tield experience DEI America is a manufacturer and distributor of small dental equipment used in the human and veterinarian fields Today our products are distributed in over 30 countries through 200 dealers In 2000 we were pleased to introduce several new patented products lur Re search and Development leam is constantly working to anticipate the practitio ner s needs and update current products In the fall of 2006 DEI America became an ISU 15480 certified company with sev eral GE approved products DBI America Corp 244 Crystal Grove Blvd Lutz FL 33848 Phone 813 909 9003 Toll 1 800 884 8007 Fax O13 909 9770 Email sales dbidental com dbiexpoert verizon net Website www dbidental cam When Wuality DEI AMERICA CORP Table of Contents Introduction Multipurpose Ultrasonic lips Clinical Studies Lertitications Accessories Limited Warranty Intormation Complete DBI Brochure Page 3 8 14 11 24 21 24 24 71 20 ZI 28 4 Page 4 To Order Call 1 800 884 3507 Swift Portabl
5. DBI AMERICA Mega Light WH 5 LED Whitening Light The Mega Light WH is a powerful but gentle bleaching light A low heat emitting 3 Watt blue LED light with a 50 000 hour life expectancy Auto memory and multiple time settings of 5 10 15 20and 25 minutes enabling efficient patient treatment The movable arm allows for easy adjustment The Mega Light WH s compact and light weight design makes it an ideal space saver Cat 3 December 2008 Mega Light CL LED Cordless Curing Light Mega Light Turbo No strings attached with the new Mega Light Cordless The latest LED Curing Light LED Technology with 1600mw cm of power Two connection options battery or direct The digital display makes operating The Mega Light Turbo 15 LED Curing light with 800mw cm of your new curing light simple and fast The Mega Light CL comes power The light offers three programs Fast Ramp and Pulse Preset equipped with three programs Fast Ramp and Pulse Preset curing times of 5 10 20 30 and 40 seconds with a beep after every curing times of 5 10 20 30 40 and 50 seconds 10 seconds The 11mm light guide offers 360 rotation Viega Light WH Mega Light Turbo 21 0 WX20 LXS 0 H 9sWX6S LXSA H 100 WX85 LX275 H 95 WXSS LX20 H Packaged Unit Dimensions cn S2SWXSOOLX10H 2408 165 135 255WX210LX65H 240WX135LX50H M Li h S i Actual Weight 10515 48 1 0105 045kg 07 Ibs 03kg 02165 0 10kg ega Ig t Packaged Unit Weight lb
6. 128lbs 58kg 20lbs 091kg 1 85 0 81 kg 04lbs 0 18kg rif LED Cordless Curing light light with 1000mw cm of power Two power options battery or direct Preset curing times of 10 20 and 30 seconds Ideal light for sealants Available Certificates 15013485 CE Mark 1 5 200 Lines 0123 254 Crystal Grove Blvd Lutz Florida USA Zip code 33548 Eletrical Safety Phone 813 909 9005 Fax 813 909 9225 Toll Free USA amp Canada 1 800 884 3507 D Email sales dbidental com or dbiexport verizon net Website ww dbidental com 510K USA 3 E DEI AMERICA CORP 204 Crystal Grove Blvd Lutz FL 33048 6460 Phone 613 909 9000 Toll 600 884 3007 Fax 818 909 975 E mail sales dbidental com or dbiexportl verizon net Website www dbidental cam
7. 14 2005 Dear Mr Fernandes We have reviewed your Section 510 premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent for the indications for use stated in the enclosure to legally marketed predicate devices marketed in interstate commerce prior to May 28 1976 the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food Drug and Cosmetic Act Act that do not require approval of a premarket approval application PMA You may therefore market the device subject to the general controls provisions of the Act The generai controls provisions of the Act include requirements for annual registration listing of devices good manufacturing practice labeling and prohibitions against misbranding and adulteration If your device is classified see above into either class II Special Controls or class it may be subject to such additional controls Existing major regulations affecting your device can be found in the Code of Federal Regulations Title 21 Parts 800 to 898 In addition FDA may publish further announcements concerning your device in the Federal Register Page 18 Ta Order Call 1 800 884 3907 Page 2 Mr Fernandes Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination th
8. CER Fig 4 Root surface scaled with Cavi Med 2000 scaler fitted with tip No TFI 10 showing one deep longitudinal groove arrow 10 ym Fig 5 A root surface scaled with Titan S scaler fitted with universal tip showing border zone arrows between control area C and scaled area where cementum seems to have split off or been torn off Bar 100 detail from Fig 5 showing border area between test area treated with Titan S scaler and control arca C Note well demarcated deep defects in root surface 50 um DEI AMERICA CORP Table Amplitude of tip movements for automated scaling devices Power settings were same as during applied in vitro experiments Working Amplitude um Scaling device Longitudinal Transversal Amdent 830 33 75 0 Amdent 830 39 112 Cavitron TFI 10 119 37 Titan S Universal 175 228 75 228 and forth strokes for the automated scalers should not influence conclusions on root surface texture Unlike control surfaces all scaled surfaces were altered The results clearly show comparatively smooth surfaces after ultrasonic scaling whereas hand and sonic scaling produced rough uneven sur faces each with a characteristic pattern probably reflecting the working principle of each instrument The longitudinal grooves of varying depth seen in the root surfaces after hand instrumentation with a brand new curette or a McBinn sharpened curette probably reflect the irregularities of th
9. first be approved in writing by Intertek The observations and test results in this report are relevant only to the sample tested This report by itself does not imply that the material product or service is or has ever been under an Intertek certification program Official Report Template ED 16 3 13 3 11 08 DEI AMERICA CORP Page 21 Report No 3071152 002 Page 3 Issued 4 22 05 DBI America Corporation Revised 09 08 08 PRODUCT DESCRIPTION PRODUCT COVERED Ultra Sonic Scaler model Swift SW03 3 Swift Portable SW03 37P SW03 38P Ultra Sonic Scaler Polisher model Maxi Sonic III MS03 SP 100 SP 100 AK SP 200 SP 200 AK PRODUCT DESCRIPTION The equipment listed in this report is ultra sonic scaler and ultra sonic scaler polisher MODEL SIMILARITY Both the Swift and the Maxi Sonic models use same power supply and similar components Both the Scaler and the Scaler Polisher models have an external power supply configuration and an internal power supply configuration ELECTRICAL RATINGS Product Voltage Current Power Frequency W External Power Supply 120 Vac 60 VA 60 Hz Swift 24 Vac 10 60Hz Maxi Sonic III 24 Vac 20 VA 60 Hz W Internal Power Supply Swift Portable 115V lA 60 Hz SP 100 SP 100 AK SP 200 SP 200 AK 115V lA 60 Hz SD 16 3 10b 9 10 02 Page 22 To Order Call 1 800 884 3507 Report No 3071152 002 Page 4 Issued 4 22 05 DBI America Corporation TEST PERFORMANCE NO 1 A representative
10. in original new condition with all the com ponents 3 Be aware that returns must be made within 6 months of original purchase date DBI to Dealer Purchase Authorized returns will be subject to 20 restocking fee No return will be accepted without prior authorization Authorization for re o Page 28 To Order Call 1 800 884 3507 Complete DEI Brochure Helping Create Beautiful Smiles M m DEI AMERICA CORP Swift Portable Ultrasonic Piezo Scaler The Swift is a portable self contained Piezo ultrasonic scaler requiring only electrical connection The unit includes an exterior water hookup and a 500 ml self pressurized reservoir that can be filled with either water or medicament The Swift features tips with linear movement to minimize noise reduce patient discomfort and speed calculus removal A fine mist during the procedures enhances visualization Autoclavable sleeve and tip eliminate the need to autoclave the handpiece and therefore increase handpiece life The scaler offers a wide tip selection including endodontic apical surgery and periodontal The Swift Portable is also available with an optional luminous handpiece Optional 70 000 Lux LED handpiece Helping Create Beauti Swift Ultrasonic Piezo Scaler The Swift is a compact table top unit with a sleek design Whether in a cabinet or table top the frontal knobs allow for easy control adjustment Gentle on patients yet
11. sample of the product was tested in accordance with the Standard s for Safety for Medical Electrical Equipment Part 1 General Requirements for Safety UL 60601 1 1 edition dated April 25 2003 CSA C22 2 No 601 1 M90 include C22 2 No 601 1S1 94 601 1 Amendment 1 1991 Supplement No 1 94 to CAN CSA C22 2 No 601 1 M90 without the requirements of Electromagnetic Compatibility The following tests were performed Test Description UL 60601 1 amp CSA C22 2 No 601 1 Clause Humidity Preconditioning Treatment 4 10 amp 44 5 Marking Durability 6 1 Power Input Limitation of Voltage 15 Protective Earthing 18 Leakage Current Before and After Humidity Treatment 19 Earth amp Enclosure Dielectric Strength Before and After Humidity Treatment 20 Mechanical Strength 21 Stability 24 Temperature 42 Overflow Spillage Leakage Humidity Ingress of Liquids 44 Cleaning and Disinfection Abnormal Operation 52 Results of the tests indicate the specimens conform to applicable test criteria SD 16 3 10b 9 10 02 DEI AMERICA CORP Page 23 Report No 3071152 002 Page 5 Issued 4 22 05 DBI America Corporation CONCLUSION A representative sample of the product covered by this report has been evaluated to the applicable requirements of the Standard s for Safety for Medical Electrical Equipment Part 1 General Requirements for Safety UL 60601 1 1 edition dated April 25 2003 CSA C22 2 No 601 1 M90 include C22 2 No 601 1
12. 2 No 601 1 M90 without the requirements of Electromagnetic Compatibility The investigation was begun on 1 24 05 and completed on 4 22 05 A prototype sample in good condition was provided by the client on 1 24 05 and tested at Intertek s Laguna Niguel CA facility Safety for Medical Electrical Equipment Part 1 General Requirements for Safety UL 60601 1 1 edition dated April 25 2003 CSA C22 2 No 601 1 M90 include C22 2 No 601 1S1 94 IEC 601 1 Amendment 1 1991 Supplement No 1 94 to CAN CSA C22 2 No 601 1 M90 Applicant DBI America Corporation Manufacturer DBI America Corporation 2909 Busch Lake Blvd 2909 Busch Lake Blvd Tampa FL 33614 USA Tampa FL 33614 USA Contact Mr Ubiraci Fernandes Contact Mr Ubiraci Fernandes Phone 813 931 3590 Phone 813 931 3590 Fax 813 931 7457 Fax 813 931 7457 This report is for the exclusive use of Intertek s Client and is provided pursuant to the agreement between Intertek and its Client Intertek s responsibility and liability are limited to the terms and conditions of the agreement Intertek assumes no liability to any party other than to the Client in accordance with the agreement for any loss expense or damage occasioned by the use of this report Only the Client is authorized to permit copying or distribution of this report and then only in its entirety Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material product or service must
13. 23 24 and loss of tooth substance was about 10 times greater than during ultrasonic scaling 19 With an amplitude of about 200 irregular loss of cementum substance appears to be unavoidable Root surface texture after scaling 159 as observed in the present study The observation of complete removal of the cementum layer in large areas and marked roughness in others raises the question of whether the surface resulting from scal ing with the Titan S is clinically acceptable The ability to remove calculus is undeniable but it may be argued that a rough surface retains plaque Complete loss of cementum has also been found to be less conducive to the regaining of lost clinical attachment than an intact layer of cementum 29 and repeated scaling at regular intervals results in macroscopic loss of tooth substance The scaling tip of the Amdent 830 piezoelectric scalersis anchored in the piezoelectric transducer by a thread socket forming a rigid unit This produces a strictly longitudinal movement pattern without any transversal component Table 1 Thus the tip moves only parallel to the root surface The Cavi tron tip is operated by an electromagnetically acti vated stack in the handpiece from which the vibrations are transmitted to the tip Stack and tip form a unit fixed to the handle by a rubber ring resulting in a flexible connection between tip and handle Tip motion is normally not linear but shows a pattern of ellipti
14. 39 45 Page li Page 12 160 Jacobson et al ro 1 cc 10 6 ARMITAGE GC Biologic basis of scaling and root planing In AnurraGE GC Biologic basis of periodontal maintenance therapy Berkeley CA Praxis 1980 78 115 Brown FH Lusow RM Cootey RL A review of applied ultrasonics in periodontal therapy J West Soc Periodontol Periodontal Abstracts 1987 38 53 00 WAERHAUG J Effect of rough surfaces upon gingival heal ing J Dent Res 1956 5 323 5 Swartz M L Pri tips RW Comparison of bacterial accu mulation on rough and smooth enamel surfaces J Period ontol 1957 28 304 7 RM MM Jr The effect of root roughness on plaque accumulation and gingival inflammation J Periodontol 1974 4 amp 146 50 Li T Morphologic studies on dental plaque formation Acta Odontol Scand 1979 37 73 9 Mirrav H D Beziehungen zwischen Plaquebildung Rau higkeit der Zahnoberfl che und Selbstreimgung Dtsch Zahnaerztl Z 1984 39 691 8 PURUCKER BRAUER G BERNIMOULIN J P Auswinkung von Parodontalinstrumenten auf die Wurzeloberflache und deren bakterielle Besiedelung Dtsch Zahnaerztl Z 1988 43 681 5 OUIRYNEN M Marecuat Busscuer HJ WeERKAMP AH Darius PL van StreewrerGue D The influence of surface free energy and surface roughness on early plaque formation J Clin Periodontol 1990 17 138 44 BADER
15. 81 94 IEC 601 1 Amendment 1 1991 Supplement No 1 94 to CAN CSA C22 2 601 1 90 without the requirements of Electromagnetic Compatibility Report prepared by Report approved by Original Signatures On File Original Signatures On File Jim Cheng John Luong Engineering Team Leader Engineering Team Leader SD 16 3 10b 9 10 02 Page 24 To Order Call 1 800 884 3507 9 Available Models Swift Portable with Ergo Ultra Light Handpiece Includes 1 Attached Erga LED Handpiece 1 4 ml 1Baz Bottle with Lid 1 Tip PESB 1 Tip 1 Tip PES7 unless specified 3 Ergobrip Ultra Light Sleeves 3 Metal Tip Wrenches Power Cord Water Hose with Disconnect Replacement IA Fuse and Tip Measuring Part SWO3 37PL 111 Part SWO03 37P220L 230V Swift Portable with Ergo Basic Handpiece Includes 1 Attached Basic Ergo Handpiece I 8 ml TBoz Bottle with Lid 1 Tip 1 Tip PES8 1 TiptPES7 unless specilied 8 Ergabrip Basic Sleeves 3 Metal Tip Wrenches Power Water Hose with lluick Disconnect Replacement IA Fuse and Tip Measuring Part SWO3 37P 111 Part SWO3 37P220 230V Page 25 Accessories To Order Call 1 800 884 3907 Scaler PE33 Is used far lingual and buccal supragingival scaling It is one af aur mast popular tips and is used for the removal of heavy calculus Recommended power Part 260830 Type U
16. ENS ers finding an widening orifices AT preparing canals removing broken Apical surgery Sterile instruments and d mma AP 2 n 2 4 canals 4 eds pem Apical Surgery Sterile lips are dia mond coated and be used for opening and clearing the root when doing retrograde operations The tips are designed with longer necks for excellent visibility and in combination with the diamond coating the ultrasonic vibrations give a higher degree of tactility and precision anne 4 e Special Purpose tips can be used for crown removal amalgam condensa Special purpose tion and application nf thixotropic ce Sabi 502500 ilk 5 3 mentation 7 9 P Wami Page 8 It Proves to have Ultrasonic Clinical Studies To Order Call 1 800 884 3907 The Clinical Studies provided were perfarmed on the Amdent Piezo Ultrasonic Scaler which is incorporated in the Swift Portable and is substantially equivalent Many years of clinical evaluations and tests prove that Ultrasonic is superior to conventional hand scaling methods and the magnetostrictive scalers Scand J Dent Res 1994 102 156 60 Printed in Denmark All Root surface texture after different scaling modalities Jacobson L Blomlo f J Lindskog S Root surface texture after different scaling modalities Scand J Dent Res 1994 102 156 60 Munksgaard 1994 Root su
17. S performed adequately for deposits removed at frequent amp reg ular intervals DENSONIC 8 MM 3300 had fastest removal of moderate to light calculus but DENSONIC had better tip designs SCALE RITE VIPER SONIC 8 MM 3300 are best values at 269 429 amp 495 respectively including cost of tips 360 light around scaler tip on SONIC FLEX LUX was rated excellent amp considered desirable feature CLINICAL SUCCESS IS THE FINAL TEST Page 13 Page 14 To Order Call 1 800 884 3507 CRA NEWSLETTER 4 April 1993 INTERNATIONAL CLINICAL RESEARCH Summaries of research deemed particularly interesting to clinicians 1 DUAL CURE RESIN CEMENTS ACHIEVE MAJOR PORTION OF CURE THROUGH EXPOSURE TO CURING LIGHT Rueggeberg F A et al Oper Dent 1993 18 48 55 Degree of monomer conversion using infrared spectra was performed on 4 dual cure resin cements Heliolink by Vivadent Mirage by Chameleon Porcelite by Kerr Ultra Bond by Den Mat using a no light exposure b 60 second light exposure through Mylar only 8 c 20 second or 60 second cure through overlying cured wafer of composite resin 1 5 mm thick Results showed auto cure alone was always lower than when specimens were exposed to light b cure 10 minutes postmix was almost always equivalent to 24 hour cure indicating insignificant contribution of auto cure following initial set 4 c claims of cure continuing over time are not warranted
18. STEN Nonsurgical periodontal therapy Thesis Malmo 1984 University of Lund Sweden Loos Kiger EGELBERG J An evaluation of basic periodontal therapy using sonic and ultrasonic scalers J Clin Periodontol 1987 14 29 33 Kerry GJ Roughness of root surfaces after use of ultra sonic instruments and hand curettes J Periodontal 1976 18 340 6 HUNTER RK O Leary TJ AH The effective nesss of hand versus ultrasonic instrumentation in open root planing J Periodontol 1984 55 697 703 BREININGER DR O LEARY BLUMENSHINE RVH Com parative effectiveness of ultrasonic and hand sealing for the removal of subgingival plaque and calculus J Peri odontol 1987 58 9 18 Scuwarez J RG Kerry GJ Smith MOR RISON EC Evaluation of hand and ultrasonic instrumen lation in root preparation J Dent Res 1988 67 Special Issue 158 IADR Abstract No 361 Jones SJ Lozpan 1 Boype Tooth surfaces treated m situ with periodontal instruments Scanning electron microscopic studies Br Dent J 1972 132 57 64 D Si vA IV Hayak RP Curiis KM Murky MJ An evaluation of the root topography following instrumen 20 30 M Ta Order Call 1 800 884 3907 tation a scanning electron microscopic study J Peri odontol 1979 50 283 90 Ritz L Hert AF RarrrrscHAck KH An in vitro investi gation on the loss of
19. UltraLight Protective Sleeve With the same features of the Ergobrip Basic Sleeve plus a built in lens for optimal light focus it will be a pleasure to hold the handpiece and there s no risk of it sliding out of your hands even when your gloves are wet Dirt resistant and easy to clean silicone surface Part 5606451 Type Sleeve Metal Tip Wrench A universal wrench far installing scaler tips on the handpiece be used with new Durabrade Max Tips and the hexagon style tips Part 4914651 Type Tip Wrench 27 To Order Call 1 800 884 3507 Limited Warranty Warranty All products are warranted to be free from defective material and work manship under normal use and service for a period of two 2 years except ultra sonic scaling tips Cassettes and Sleeves which are only warranted for a period of three 3 months from the date of delivery to the buyer proof of invoice required DBI s sole obligation under this warranty is to repair or at its option replace the defective part of the product provided the part or product is returned to its facility with prepaid postage delivery or freight charges In the event warranty service must be performed to correct any defect only DBI shall provide this service upon mutually agreeable arrangements made in advance DBI and its distributors will not accept the return of goods unless authorized in writing prior to the return of any shipment The Shipment must be made
20. Working mode coding easy and safe setting of tip power 40 4 Ende function max 60 Max 70 iie better reachability and less shadows Solid tight connection to the handpece enhanced working UN Scaling tips are precision and cleanabiity YA available in a large P 5 variety af designs x SO as to remove V tartar and calculus on all af a 8 surface The range includes tips for Periodontics Scaling both supragingival and subainaival Aa SS PER foe PE AQ PEMA a en LA scaling Different PE 32 E if ix sedium PEMF madels are available J 14 PEAQR i in both left and right fo PE 33L P d angle versions to further enable access to furca tions S PEP P IM 1 1H 1 S WANI i Minimally invasive excavation Minimally Invasive far small prepara Mi Excavation Tips d are diamond coated Endodontics tions crown mar Endodontic tips are 2 m gins cleaning excellent in the fissures and can be removal nf posts dibus fans EN 10 used for treating 4 hildren and nerv the removal of ie 08 i EI EN dentin in pulp cham j nus patients by the low noise levels b f 4 EN 4 See
21. above has established and is maintaining a quality system which meets the requirements of the listed standard s See also notes overleaf p TE cc Lu c co cr co TE a ud co c oO uL c D li Report No DM804523 102 5 Xi M u B Valid until 2011 09 30 HA Date 2008 10 23 Hans Heiner Junker Page 1 of 2 TUV S D Product Service GmbH X Akkreditiert durch Su Zentralstelle der Lander Zer fizierstelle Peg d f r Gesundneitsschutz i neimi Ridlerstr 65 80339 M nchen ZERTIFIKAT CERTIFICATE Germany ac ZLG ZQ 999 98 12 46 Page Dertificatinns CE Certification ee cr c ec LLJ co ce lt I TH ecc co lt LL co fam 23 og ZERTIFIKAT CERTIFICATE To Order Call 1 800 884 3907 EC CERTIFICATE Wer Full Quality Assurance System Annex section 3 of the Directive 93 42 EEC on Medical Devices No G1 08 07 67012 001 Manufacturer D B I AMERICA CORPORATION 254 Crystal Grove Blvd Lutz FL 33548 USA EC Representative Maecolux S A 32 Demier sol Residence Dali G D Luxembourg 25436 Luxembourg LUXEMBOURG Product Dental Piezo Ultra Sonic Scaler Category ies Combination Dental Piezo Ultra Sonic Scaler with Dental Elec
22. aking money paid to Profitfinder clearly evident in annual membership fee rather than part of product cost amp 3 reduced annual cost of dental products for users by about 25 Profitfinder does not sell products it simply lists various costs charged for a product by dealers across U S Profitfinder members are informed of costs via quarterly listings in booklet or computer disk or via contact by fax or toll free telephone number Clinicians select their own purchase source which can be their local dealer a dealer anywhere in U S or one of four major supply houses who have agreed to sell to Profitfinder members for lowest cost found nationally by Profitfinder Some dental retailers complain Profitfinder amp other national shopping services threaten their business because services they provide to dentists force them to charge more These services include 1 Sponsorship of local state amp national dental meetings 2 Equipment maintenance 3 Sales force that calls on offices 4 Providing exchanges amp or refunds on products returned by clinicians 5 Loaner equipment 6 Maintenance of local inventories 7 Personnel listings 8 Scholarships amp loans for students 9 Office planning 10 Business counseling etc Mention of these points by dealers is valid Also valid is fact that clinicians realize it is they amp ultimately their patients who pay for these services Services provide dealers with goodwill amp rec
23. ase for mobility and storage High torque brush motor with speed up to 20 000 rpm The Flash DP is an efficient and reliable Electric Micro Motor High torque brush motor reaching speeds of up to 35 000 rpm Compact and light weight for effortless mobility and storage Compact and ergonomic design Built in motor cradle and bit stand One touch motor rotation direction changer Automatic circuit protection system reset function Variable speed foot pedal or hand controlled speed Accepts disposable Contra Angles Optional E type motor lyear warranty Compact and Light Weight Cordless Battery Operated Rechargeable 140 minutes of operation when using battery Also operates directly connected to AC Power Easy operation with Power and Variable Speed Control Switch Forward Reverse Rotation Activated by either foot control or hand control Accepts disposable Contra Angles Optional E Type Motor with Contra Angle amp Straight Attachments Carrying Case and Holster included 1 year warranty FlashDP Flash Pertable Packaged Unit Dimensions in 14 0 W X 1051 X 5 0 H 14 0 W X11 5 L X 4 0 H Packaged Unit Dimensions 360WX265LX120H 360WX290L X 10 5H Actual Weight 3218 15i9 __ osig Packaged Unit Weght Ibi 6 5155 3 0kg 45lbs 2 1kg Voltage Hz 115V 240V 50 60Hz 115V 240V 50 60Hz 2 Year Warranty Limited Warranty 2 Year Warranty Optional E type electric motor kit
24. at your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies You must comply with all the Act s requirements including but not limited to registration and listing 21 CFR Part 807 labeling 21 CFR Part 01 good manufacturing practice requirements as set forth in the quality systems QS regulation 21 CFR Part 820 and if applicable the electronic product radiation control provisions Sections 531 542 of the Act 21 1000 1050 This letter will allow you to begin marketing your device as described in your Section 510 k premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to praceed to the market If you desire specific advice for your device on our labeling regulation 21 CFR Part 801 please contact the Office of Compliance at 240 276 0115 Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807 97 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers International and Consumer Assistance at its toll free number 638 2041 or 30 1 2 ar at its Internet address fda covi ed support index html yours ka Pichon ie Chiu Lin Ph D Director Di
25. c Motor The 5 200 is a self contained Scaler Polisher worksta tion The unit requiring only electrical connection includes a 500 ml self pressurized reservoir that can be filled with water or medicament The Ideal unit for clinics requiring extra mobility or for offices without plumbing Scaler tips offer linear movement to speed calculus removal and minimize noise and heat Wide tip selection including endodontic apical surgery and periodontal The SP 200 is also available with an optional lighted scaler handpiece Standard E Type motor accepts most E type attachments Optional lab or upgrade E type electric motor available Optional E type electric motor kit 200 90 W X 1001 X 3 5 H 22 9W X 25 4L X 8 9H 12 1 W X9 3 L X 5 5 H 30 8W X 23 51 X 16 5H 45lbs 2 1kg 70155 3 2kg 28 000Hz to 30 000Hz 010 35 000 rpm 115V 60Hz or 230V 50Hr External Dimensions in External Dimensions cm Packaged Unit Dimensions ir Packaged Unit Dimensions cm Actual Weight Packaged Unit Weight Ib Scaler Power Electric Motor Speed Voltage Hz Limited Warranty 2Year Werranty Optional 70 000 Lux LED handpiece Flash Portable Polisher amp Drill Flash DP Table Top Micromotor Great things come in small packages The Flash Portable is a compact and light weight cordless combination polisher and drill The Flash Portable features a high quality recharge able Ni Mh battery and a convenient carrying c
26. c or circular movement Table 1 Although a transversal movement was recorded for the Cavitron tip while no such vector was seen for the Amdent tips the scaled surfaces were similar in texture It thus appears that the transversal compo nent of thc Cavitron tip 27 um with medium power setting is insufficient to produce any detectable ef fects on root surface texture Earlier reports of rough surfaces after Cavitron scaling 30 34 prob ably reflect the result of operating the equipment with a high power setting and such reports may ex plain the earlier recommendations to perform root planing with hand instruments after ultrasonic scaling Although differences in surface texture were found among the different modes of scaling it re mains to be determined whether these differences are of clinical significance It appears from the litera ture that subgingival root surface texture is not im portant for periodontal healing However it can be argued that a rough root surface supragingivally re tains plaque better 5 6 than a smooth and thus requires a higher standard of oral hygiene of the pa tient Thus instruments which produce an excessive root surface roughness should be avoided Acknowledgments This study was supported by a grant from the Swedish Medical Council No 6651 References 1 ALEO JJ Renzis FA FARBER PA In vitro attachment of human gingival fibroblasts to root surfaces J Periodon tol 1975 40 6
27. e Piezo Ultrasonic Scaler The Swift Portable is a efficient portable self contained Piezo Ultrasonic Scaler requiring only electrical connection The unit includes an exterior water hook up and a oUUml self pressurized reservoir that can be filled with either water or medicament The Swift features an array af tips with linear movement to minimize noise reduce patient discomtort and speed calculus removal A fine mist and an optional LED handpiece enhances visualization Autoclavable sleeves and tips eliminate the need to autoclave the handpiece and therefore increases handpiece life Featured here with Part SWO03 37PL the Erga Ultralight LED Handpiece Benefits Technical Data e 28 000 30 000Hz of Power Optional 70 000 Lux LED Handpiece External Dimensions b a WX8 2 LXB 8 in X21 BL 1 large 500ml IBoz Battle T e last Handpiece System to take you trom one patient to the next effortlessly e Wide Tip Selection including Endodontics Apical Surgery Actual Weight 3 0 Ibs Lb kg and Periodontal e Frontal Controls for better Accessibility 78 000 Hz 30 000 Hz e Smooth Surface for easy Asepsis e Set Composed of Three lips Three Sleeves and Three Water Consumption ID ml min o0 ml min Wrenches e Compact Lightweight and Self Contained Limited Warranty 2 Years Warranty DBI AMERICA CORP Page 5 The Ergo Experience Ergonomics the science of designi
28. e edges of the hand instruments Fig 2 Because the McBinn sharpened curette produced almost the same pattern as the brand new curette the sharpening procedure may have been insufficient to eliminate all irregular ities of the edge Moreover the operating procedure of the hand instruments exerted a higher pressure 500 Pa on the scaled root surface than did that of the ultrasonic scalers 50 Pa Thus it was apparent that hand instruments produced a rougher root sur face and probably removed more tooth substance than ultrasonic scalers The tip movement of the three automated scalers is generated by different principles resulting in varying amplitudes and patterns of movement Table 1 These differences may explain the ob served variations in root surface texture Theoreti cally a longitudinal movement parallel to the root surface might result in a less pronounced abrading effect on the root surface than a transversal motion perpendicular to the root surface In a clinical 861 ting the latter involves a hammering movement on the root surface The tip of the Titan S scaler is activated by an eccentric bar operated by an air turbine This elicits tip movements in a three dimensional pattern 27 28 The transversal component of the pattern of movements appears to be at least as large as the longitudinal component Table 1 Consequently Titan S tips show a rather unpredictable movement pattern resulting in uneven root surfaces
29. equency ampliltude amp path of motion type of energy source amp cavitation Instead clinical differences were power of ultrasonics vs sonic instruments access achieved by handpiece amp tip designs amp convenience features WHAT ARE COMMON OPERATOR ERRORS A Tip not parallel to long axis of tooth amp point of E Failure to flush H O lines before amp after each use tip used to scale tooth F Failure to replace tips at regular intervals About B Excessive pressure placed onto tip during scaling every 6 12 months depending on frequency of use C Failure to use owest effective power setting G Failure to keep tip in constant motion D Failure to use adequate H O flow to cool tip H Failure to read amp adhere to instruction manual Modification of tip size amp or shape by ciinician CRA CONCLUSIONS Ultrasonic amp sonic scalers can differ clinically Scaling efficiency was not related to mechanical characteristics but to handpiece amp tip designs available energy amp convenience features e ULTRASONIC ENERGY was needed to remove tenacious deposits AMDENT 830 removed gross calculus fastest but CAVITRON 3000 PIEZON MASTER amp AUTOSCALER removed calculus rapidly amp had better tip designs LE CLEAN MACHINE amp 25 30 TURBO are best values with high ratings for calculus removal amp tip designs amp cost of 395 amp 475 respectively not including tip cost of 60 each eSONIC SCALER
30. feel makes it a pleasant Ergo Experience The handpiece can be 4 4 4 5 AA isconne i 6 LED diodes with a lifetime of approximately 100 000 hours or more than 30 years of regular 2 use LED light gives more visibility makes The silicon grip ErgoGrip UltraLight gives a treatment more efficient and 2 p superior control Less work for your fingers decreases eye strain i e 5 less risk of slipping and easier to clean b The handpiece is ergonomically shaped to give optimal traction for your fingers sealed lo deter bacieria pockets and guarantee excellent hygiene E ES gt gt Built in lens in the grip for simple and cost effective changing Why LED Most scalers and hand instruments Scalers with light generally use Ergo UltraLight Handpiece uses LED are not equipped with light but de halogen light that provides approx Lights which provides approx pend onthe units overhead lights 10 000 Lux only 70 000 Lux which makes it superior to other lights in today s current market DBI AMERICA CORP Page 7 Multi Purpose Ultrasonic Tips A Tip for You b9 different tips solutions for Periodontics NW Endodontics Apical Surgery Restorative and Sterile treatment All tips are made with the Duralirade Max high wear resistance steel with a velvet polishing tor less reflection Velvet polshing i ess reflection
31. ghness although some recent reports have indi cated the reverse 23 24 As indicated above reports disagree on the effect of different scaling instruments on root surface texture In addition sonic and piezoelectric scalers have only to a limited extent been compared with earlier scaling methods Since maximal root surface smoothness is one of the recommended objectives of scaling we considered it of interest to study root surface texture after scaling with various manual and automated scaling instruments available on the market Material and methods Forty eight human teeth extracted for orthodontic reasons were immersed in a 10 aqueous solution of sodium hypochlorite for 30 min and then rinsed thoroughly in running tap water The lingual sur faces of the teeth were planed with a diamond stone to facilitate later mounting for scanning electron microscope SEM examination The teeth were randomly divided into six groups Half of the buc cal root surface in all teeth was scaled with either hand instruments or different ultrasonic or sonic scalers the other half serving as untreated control The test and control areas were outlined by one apical and one coronal transversal groove sepa rated by a distance varying between 6 and 10 mm DEI AMERICA CORP Group I The root surfaces were treated with a brand new curette McCall 13 14 LM Dental Turku Finland The curette was applied with the face at an angle of 80 85 t
32. handpiece amp scaler tip design rather than energy source B 50 SCALERS All sonic scalers use compressed air amp water delivered through hose designed for high amp low speed handpieces Air moves rotor system within scaler that vibrates working tip in elliptical pattern at frequency of about 2 000 6 000 cps Although energy is not high enough to remove tenacious deposits it is well suited for less tenacious deposits typical of patients treated frequently WHAT ARE ADVANTAGES amp DISADVANTAGES FOR USE OF AUTOMATED SCALERS A ADVANTAGES 3 Amount of coolant water necessary for magneto 1 Rapid removal of gross calculus strictive systems can be difficult to suction 2 Improved patient comfort 4 Cost of instruments 3 Improved operator comfort 5 Infection control limitations Handpieces of most ultrasonic 4 Simultaneous water lavage amp scaling Some have scalers cannot be heat sterilized ability to deliver medication lavage during scaling 6 Space required for ultrasonic scaler control unit B DISADVANTAGES in critical area of operatory 1 Less or no tactile sense 7 Noise can be irritating to some people 2 Reduced control in difficult access areas 8 Ultrasonics may interfere with pacemakers DO VARIOUS DESIGNS DIFFER CLINICALLY Chart on pages 2 3 summarizes 22 instruments YES CRA studies showed clinical superiority could not be determined by characteristics measurable in lab such as tip fr
33. in accordance with the distributor s instructions Except as otherwise provided herein there is NO WARRANTY rep resentation or condition of ANY KIND express or implied including NO WAR RANTY OF MERCHANTABILITY OR FITNESS and none shall be implied by law THE EXPRESS WARRANTY AND REMEDIES CONTAINED HEREIN 1 ARE MADE SOLELY TO THE FIRST PURCHASER FOR BENEFICIAL USE THE BUYER 2 ARE THE SOLE WARRANTIES AND REMEDIES 3 ARE IN LIEU OF ALL OTHER WARRANTIES GUARANTEES AGREEMENTS OR OTHER LIABILITIES WHETHER EXPRESS OR IMPLIED AND ALL OTHER REMEDIES FOR BREACH OF WARRANTY OR ANY OTHER LIABILITY OF THE MANUFACTURER IN NO EVENT SHALL D B l AMERICA BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES No person agent distributor or dealer is authorized to change modify or extend the terms of the warranty in any manner whatsoever This Warranty is void when failure of defect is caused by conditions beyond DBI s control such as damage resulting from mishandling neglect misuse im proper maintenance accident or alteration or repair by anyone other than an au thorized dealer Do not send your product for repair directly to the factory or any ad dress in the user manual Always contact your local dealer Return Merchandise Before we can consider your request for returns please 1 Provide the copy of the DBI invoices for each product 2 Be sure products have not been used Merchandise must be returned in the original packaging and
34. ng the job equipment and work place to fit the user tn minimize or prevent repetitive strain inju ries which can develop over time Ergo Basic Handpiece The Ergo Basic handpiece is designed with the user in mind With it s feath erweight lightness and it s soft sili cone feel the Ergo Handpiece makes your work more etticient and pleas ant without causing fatigue to the user Autoclavable lips and Sleeves eliminating the need to autoclave the handpiece and theretore increases handpiece lite 7 n qua n G ns ttvHP H n A ErgoGrip Basic Sleeve e Design with a special traction surface for better grip superior control and less risk of slipping e Silicone absorbs vibration for superior 5 24 comtort e Minimizes fatigue on fingers and hands e Silicone surface is dirt resistant and easy to clean 17000 e hutaclavable to prevent contamination Handpiece jand Ergabrip Basic and promotes excellent hygiene and Sleeve satety Oo rae Se 7 Page B To Order Call 1 800 884 3507 Cy nd then there was Light Ergo Ultra Light Handpiece The Ergo Ultra Light Handpiece is a premium handpiece with LED illumination giving more visibility and making wark more efficient by removing the uncertainty that everything you want to remove is actually gone Also equipped with autoclavable tips and sleeves increasing handpiece life Its featherweight lightness and silicone
35. niversal Heavy Calculus Removal Scaler Tip PE38 It is primarily used far subgingival scaling but can also be used for light supragingival scaling It is longer than 33 and has the same ergonomic design as lip 37 Bath far lingual and buccal use Available in Lett or Right Angle Recommended Part 5608371 Type Periodontics Scaler Tip PE37 Has a wide range of uses and can be used far both supragingival and subgingival treatments The slim tip reaches easily into deep pockets and can also be used far furcatians Available in Left ar Right Angle Recommended power setting 10 70 Part 5608341 Type Univeral Scaler 7 Is used for lingual and buccal supragingival scaling Recommended for the removal of gross calculus Recommended power setting 10 00 Part 5608291 Type Hoe Heavy Calculus Removal More tips and accessory information available upon request DEI AMERICA CORP Accessories Page 26 Scaler PE33 Is designed for subginigival scaling and can also be used far furcatians Available in Left or Right Angle Recommended power setting 10 70 Parti 5608311 Type Periodontics ErgoGrip Basic Protective Sleeve Silicone sleeve for minimal torque an fingers and hands Eliminates uncomtortable vibrations and designed with a special traction surtace for better grip lo be used together with The Ergo Basic Handpiece Part 4516331 Type Sleeve ErgoGrip
36. o the root surface according to generally accepted principles 25 The curettes were applied with a pressure to the root surface of approximately 500 Pa Each test surface was exposed to 10 pull strokes Group 2 The root surfaces were treated with a curette similar to the onc in Group 1 resharpened by the McBinn method McBinn St Paul MI USA to improve edge smoothness as stipulated by the manufacturer Each test surface was exposed to 10 pull strokes Groups 3 and 4 The root surfaces were treated with 10 back and forth strokes with an ultrasonic piezoscaler Amdent 830 Amdent AB Nynis hamn Sweden fitted with tip No 33 Group 3 or tip No 39 Group 4 The lateral side of the tip was applied to the root surfaces with the handle not deviating more than 10 from the long axis of the tooth A pressure not exceeding 50 Pa was employed The power setting was medium Group 5 The test surfaces were treated with 10 back and forth strokes with an electromagnetic scaler Cavi Med 2000 Dentsply New York NY USA fitted with tip No TFI 10 and applied to the root surface as described for Groups 3 and 4 A pressure not exceeding 50 Pa and a medium power setting were used Group 6 The test surfaces were treated with 10 AR pe Fig 1 Unscaled control area showing mosaic like cementum surface Bar 10 Fig 2 Hand instrumented root surface with vow Root surface texture after scaling 157 double stroke
37. ognition they hope will attract more customers amp services provide clinicians with convenience amp support Questions about shopping service concept are 1 s there a place for everyone in dental market dealers catalog suppliers 8 national shopping services 2 a dealer is serving amp determining pricing fairly what is there to fear 3 Is it restraint of trade amp price fixing when a dealer pressures a manufacturer to withdraw right to sell products from dealers who choose to sell at lower prices 4 Is not freedom to set prices essential to free enterprise system In spite of objections national amp international shopping services are trend of future for at least some purchasers Several groups are now working on ingenious ways to combine computer networking amp or faxes amp private labeling to offer new fast economical marketing CRA did not conceive these ideas CRA only evaluates efficacy amp clinical usefulness Therefore why should CRA report be disputed 15 there something amiss in pricing of dental products Why isn t there a place for many types of retailers in today s marketplace KKkKKK Products published in the CRA Newsletter have been selected on the basis of merit trom hundreds of products under evaluation CRA conducts research at 3 levels 1 Basic science laboratory research 2 Controlled long term clinical research amp 3 Multiplo user field evaluations 40 ful timo employees wo
38. ough scaling regardless of tvpe of instrument removes calculus efficiently and produces an ac ceptable root surface for soft tissue healing 11 12 This appears also to be the case without the often recommended final step of root planing 11 However the root surface appearance after scaling has been reported to show differences in texture depending on the type of instrument Some dentists maintain that scaling with hand instruments produces a smoother root surface than ultrasonic scalers 13 15 Others assert that there is no difference between the two methods 16 while still others find ultrasonic scaling to be supe rior to hand instrumentation both in smoothness 17 20 and ability to remove subgingival calculus 14 and plaque 15 21 The ultrasonic scalers in all of the above studies generate tip vibrations through magnetostrictive power generation A new generation of ultrasonic scalers utilizes the piezoelectric principle of power generation The two different ways of generating tip vibrations may be expected to show differences in clinical performance when applied to a root surface although detailed knowledge is lacking Sonic scalers are the latest addition to automated scaling instruments They are reported to produce Accepted for publication 11 September 1993 root surfaces comparable to surfaces after ultra sonic scaling at a medium power setting 22 while ultrasonic high power produces greater surface rou
39. powerful with 28 000 30 000 HZ The ability to see your work Piezo Ultrasonic scalers use less water than traditional scaling methods Unit includes autoclavable tips sleeves and wrenches The Swift is also available with an optional luminous handpiece Swift Portable External Dimensions in 6 3 W X B 5 L X 6 5 H rename asm rem C oo 6 3 W X8 5 L X 5 8 H 16 5W X21 6L X 14 6H 12 1 W X 9 3 L X 6 5 H 30 8W X 23 51 X 16 5H 3 3165 1 5kg 60lbs 2 7kg 28 000Hz to 30 000Hz 115V 60Hz or 230V 50Hz 2 Year Warranty Biojato Bicarbonate Powder Jet Finally a prophylaxis unit that goes where you go Take this system from room to room connect to any high speed tubing and you re ready to work The Biojato utilizes the delivery unit s air water and foot control Water air and powder come together at the tip this feature helps prevent clogs Air filter removes humidity from the air to prevent blockage Removable polishing handpiece for easy sterilization Gently removes stains and plaque from all surfaces including interproximals Portable weighs less than 2165 1 year warranty Packaged Unit Dimensons 8 5W X B 5L X 6 0H in 22W X 22 0L X 22 0 cm 2 2Lbs 1 1Kg Limited Warranty Ful smiles Page 29 Page 30 To Order Call 1 800 884 3507 SP200 Portable Combo Piezo Ultra Sonic Scaler and Electri
40. rface texture after scaling with hand instruments ultrasonic scalers Amdent 830 and Cavi Med 2000 and a sonic scaler Titan S was assessed in vitro The experimental material consisted of 48 extracted human teeth divided into six groups Root surface texture was assessed with scanning electron microscopy SEM Hand and sonic instrumentation produced large grooves and removed cementum evident at a magnification of x 70 while the root surface alterations after ultrasonic instrumentation were not detectable below a magnifi cation of x 500 The working principle of cach scaling instrument in relation Copyright Munk DENTAL RESEARCH ISSN 0029 44 5 oaara L994 Lars Jacobson Johan Bloml f and Sven Lindskog Department of Periodontology Postgraduate Dental Education Center Orebro County Council Orebro and Department of Oral Histology and Cell Biology School of Dentistry Karolinska Institutet Huddinge Sweden Key words automated scalers hand instrument scanning electron microscopy teeth roots Lars Jacobson Anggatan 54 S 702 24 rebro Sweden to its effect on the root surface was discussed The objective of scaling and root planing is to create root surface which is biologically accept able to the surrounding healing soft tissues 1 23 and which is sufficiently smooth to facilitate oral hygiene procedures and retard microbial recoloni zation 4 10 Available literature indicates that thor
41. rk at the institute amp over 300 clinical field evaluators are located throughout the world All professional staff volunteer their time Neither the Director nor the Evaluators receives a salary A product must meet at least one of tha following standards to be reported in this publication 1 Innovative amp now on tho market 2 Loss expensive but moots tho use standards 3 Unrecognized valuable classic 4 Superior to others in its broad classification Your results may differ from CRA Evaluators or other researchers on any product because of differences in preferences lechniques batches of products amp environments CRA is a non profit corporation conceived to serve dentistry All proceeds are used to support the work of CRA amp the CRA Foundation a tax exempt foundation This Newsletier or portions thereof may not be duplicated without permission of CLINICAL RESEARCH ASSOCIATES Annual subscription 49 DEI AMERICA CORP Page 15 Certifications ISO 13485 Certification CERTIFICATE Product Service No QN 08 07 67012 002 Holder of Certificate D B l AMERICA CORPORATION 254 Crystal Grove Blvd Lutz FL 33548 USA Certification Mark Scope of Certificate Design and Development Production Service and Distribution of Dental Piezo Ultra Sonic Scaler Combination Dental Piezo Ultra Sonic Scaler with Dental Electric Motor The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned
42. root substance in scaling with various instruments J Clin Periodontol 199 18 643 7 LADNER JR Lin Beck JR HORTON JE An SEM study of root surfaces following planing by hand and two distinct types of ultrasonic instruments J Dent Res 1992 71 224 Special Issue Abstract No 947 Barri P Tuno B Carris B Perser D Effects of ultra sonic and sonic scalers on dental plaque microflora in vitro and in vivo J Clin Periodontol 1992 19 455 9 Lexnes KN Evaluation of the effect on root surfaces of air turbine scalers and ultrasonic instrumentation J Periodontol 1985 86 522 3 Sivers Jounson GK Comparison of effects of ultra sonic and sonic instrumentation on amalgam restorations Gen Dent 1989 37 130 2 NE Lir T LEKNES KN Comparative in vitro studies of sonic ultrasonic and reciprocating instruments J Clin Periodontol 1992 19 560 9 PARR RW GREEN MADSEN L MILLER 5 Subgingival scaling and root planing Berkeley CA Praxis 1976 31 Sputter coating techniques for scanning electron microscopy SEM TITRI 1975 7 1019 28 27 Onsen HC Arbeidsspissens virkemate hos ultralydsinstru menter og turbinscalere Nor Tandlegefor Tid 1985 95 689 92 GANKERSEER EJ WALMSLEY AD Preliminary investigation into the performance of a sonic scaler J Periodontol 1987 58 780 4 BLOML F L LINDSKOG APPELGREN
43. rrows Bar 10 um Page 8 Page ID 158 Jacobson et al appearance indicative of cementum Fig 1 In general all the cementum surfaces showed a smoother and more regular appearance in the coro nal half of the control areas than the apical half Thus the following assessments and comparisons were made in the coronal parts of the test and control areas to exclude possible influence of root surface irregularities The root surfaces in each treatment group showed uniform alteration pat terns with three clearly distinguishable surface ap pearances depending on treatment The different root surface appearances will be described accord ing to treatment group Groups 1 and 2 The hand instrumented cemen tum surfaces displayed similar surface textures irre spective of the quality of the cutting edge of the two instruments Grooves and excavations running parallel to the long axis of roots were clearly visible at a magnification of x 70 Fig 2 The grooves sometimes crossed over each other indicating some overlapping strokes Groups 3 4 and 5 Only minor surface alter ations were visible on a smooth cementum surface Excavations were seen running parallel to the long axis of the roots Even at a magnification of x 500 the excavations were less pronounced than those seen in Groups 1 and 2 Fig 3 Occasionally larger and apparently deeper excavations were found in the scaled areas Fig 4 Nes Lot i PI EIS
44. s with a sonic scaler Titan S Star Dental Syntex Dental Products Valley Forge PA USA fitted with a universal tip and applied to the root surface as described for Groups 3 and 4 A pressure not exceeding 50 Pa and an air pressure of 3 bar were used After scaling the teeth were fixed in 10 neutral buffered formalin After dehydration in a graded series of ethanol with 10094 acetone as the final step the teeth were mounted on aluminum stubs gold coated with a sputter technique 26 and ex amined in a Jeol SEM operated at 5 0 kV and at tilt angles between 0 and 40 Amplitude measurements The tip movements of the sonic and ultrasonic instruments were mea sured with a light microscope fitted with a measur ing graticule Epimicroscope IM 35 Zeiss Ober kochen Germany The maximum amplitude of each tip was measured both along the long axes and at right angles to the long axes of the hand pieces holding the tips This corresponds to a movement of the tips parallel and at right angles to the root surface respectively Results No periodontal soft tissue remnants were ob served in either test or control areas In most specimens small cracks were seen presumably arti facts from the dehydration process The control areas showed an even mosaic like longitudinal grooves Control area Bar 10 Fig 3 Root surface scaled with Amdent 830 scaler fitted with tip No 33 showing shallow longitudinal grooves a
45. sonic amp sonic automated scalers 2 What are advantages amp disadvantages of automated scalers 3 Do various designs differ clinically amp 4 What are common operator errors Report below addresses these questions bh 5 WHAT ARE ULTRASONIC amp SONIC AUTOMATED SCALERS Clinically most obvious differences between ultrasonic 8 sonic scalers are a Scaling power Ultrasonics can remove tenacious deposits while sonics are best suited for routine recall patients 8 b Delivery systems Ultra sonics require separate unit amp controls or can be built into unit delivery system while sonics attach to existing air water hose amp are controlled by handpiece foot pedal A ULTRASONIC SCALERS 2 types exist 1 Magnetostrictive i e Cavitron by Dentspy amp 2 Piezoelectric e Amdent 830 by Amdent AB Sweden In magnetostrictive systems electrical energy is applied to coil in handpiece amp magnetically changes dimension of metal stack creating elliptical or linear movement of tip at frequency of about 25 000 30 000 cycles per second cps Significant heat is generated amp requires water for cooling In piezoelectric systems electrical energy is applied to crystal which emits vibrations in linear pattern at frequency of about 25 000 40 000 cps Almost no heat is created so water is for lavage only Both types of scalers can remove tenacious deposits well Clinical differences are attributable to access provided by
46. tric Motor The Certification Body of S D Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design manufacture and final inspection of the respective products product categories according to Annex section of the Directive 93 42 EEC on Medical Devices This quality assurance system conforms to the provisions of this Directive and is subject to periodical surveillance For marketing of class Ill products an additional Annex 11 4 certificate is mandatory See also notes overleaf Report No DM804523 102 Valid until 2013 10 22 HA Hans Heiner Junker Date 2008 10 23 TUV S D Product Service GmbH is Notified Body according to Council Directive 93 42 EEC concerning medical devices with identification no 0123 Page 1 of 2 T V SUD Product Service GmbH Zertifizierstelle Ridlerstrasse 65 80339 M nchen Germany DEI AMERICA CORP Page 17 Certifications SIOK Certification DEPARTMENT OF HEALTH amp HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard SEP 2 2005 Rockville MD 20850 Mr Ubiraci R Fernandes Vice President D B I America Corporate 2909 Busch Lake Boulevard Tampa Florida 33614 Re K051910 Trade Device Name Ultrasonic Scaler Regulation Number 21 CFR 872 4850 Regulation Name Ultrasonic Scaler Regulatory Class Product Code ELC Dated June 24 2005 Received July
47. vision of Anesthesiology General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure DEI AMERICA CORP Page 19 E1 Indication for Use 510 number if known 0519 0 Device Name Ultrasonic Scaler 21CFR872 4850 Indication for use The Ultrasonic Scales is intended to be used by a dentist and or dental hygienist for use during dental cleaning to remove calculus deposits from the teeth Prescription un Per 21 CFR 801 109 ets inne vision Of Anesthesia Infection Control De Hospital 51015 JAIO Page 20 To Order Call 1 800 884 3507 Evaluations and Tests Performed CLASSIFICATION REPORT INTERTEK TESTING SERVICES NA INC 27611 La Paz Road Suite C Laguna Niguel CA 92677 Job No 3071152 108 Issued April 6 2005 Page 1 of 43 REPORT NO 3071152 002 INSPECTION TESTS AND EVALUATION OF ULTRASONIC TEETH CLEANERS RENDERED TO DBI AMERICA CORPORATION TAMPA FL GENERAL This Report gives the results of the inspection tests and evaluation of ultra sonic scaler and ultra sonic scaler polisher for compliance with applicable requirements of the Standard s for Safety for Medical Electrical Equipment Part 1 General Requirements for Safety UL 60601 1 1 edition dated April 25 2003 CSA C22 2 No 601 1 M90 include C22 2 No 601 1S1 94 601 1 Amendment 1 1991 Supplement No 1 94 to CAN CSA C22
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