tün® ultrasonic tips product family

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 7, 2019 Engineered Endodontics % John Ziobro Principal Consultant SpectraMedEx, LLC 3215 Golf Road #1459 Delafield, Wisconsin 53018 Re: K182145 Trade/Device Name: tün® ultrasonic tips product family Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: April 24, 2019 Received: May 1, 2019 Dear John Ziobro: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Malvina B Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182145 Device Name tün® ultrasonic tips product family #### Indications for Use (Describe) tim® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodonic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY Section 3 ## K182145 Traditional 510(k) Summarv - 1. Summary Date: June 1, 2018 - Applicant Name: Engineered Endodontics, LLC 2. W134 N4965 Campbell Drive Menomonee Falls, WI 53051 Establishment Registration Number: 3012322979 - 3. Submission Correspondent: On behalf of Engineered Endodontics, the following consultant is assigned the responsibility of submission correspondence: John F. Ziobro, Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: 262.719.8922 - 4. Trade Name: tün® ultrasonic tips product family - న. Common Name: Scaler, Ultrasonic - 6. Description: tün® ultrasonic tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The tün® ultrasonic tips are made from 17-4ph Stainless Steel. Alloy 17-4ph (UNS S17400), Type 630, is a chromium-nickel-copper precipitation-hardening martensitic stainless steel with an addition of niobium. The tips will be available in M3xO.5 and M3x0.6 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals. Certain models have diamond (zirconium nitride) coating. - 7. Manufacturing Site: Engineered Endodontics, LLC W134 N4965 Campbell Drive Menomonee Falls, WI 53051 Establishment Registration Number: 3012322979 - 8. Classification Regulation, Class, Product Code, Description & Panel: | Regulation # | Class | ProCode | Description | Panel | |---------------|-------|---------|--------------------|--------| | 21CFR872.4850 | II | ELC | Scaler, Ultrasonic | Dental | Predicate Device(s): Predicate: 9. 510(k) Number: K132609 ESSENTIAL DENTAL SYSTEMS, INC. Manufacturer: 89 Leuning Street, Suite 8 South Hackensack, NJ 07606 Trade Name: EDS ULTRASONIC TIPS Classification Regulation, Class, Product Code, Description & Panel: | Regulation # | Class | ProCode | Description | Panel | |---------------|-------|---------|--------------------|--------| | 21CFR872.4850 | II | ELC | Scaler, Ultrasonic | Dental | tün® ultrasonic tips Product Family Traditional 510(k) Submission {4}------------------------------------------------ - 10. Proposed Indication for Use: tün® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages. - 11. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared: - ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]. The application of this standard resulting in testing to: - ISO 10993-5:2009 / (R) 2014 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity - ISO 10993-10:2009 / (R) 2014 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization - ISTA 3A General Simulation Performance Test Procedure: Packaged- Products for Parcel Delivery System Shipment 150lbs or less - 12. Technological Characteristics The proposed device is similar to the predicate device and as substantially equivalent technological characteristics. - 13. Comparison to Predicates The main differences between the tün® ultrasonic tips under review and the predicate device cleared under K132609 are as follows: - The proposed device is plated while the predicate device is not. This difference is a function of the manufacturing method and does not affect the overall safety or performance of the device. Note: The predicate device chosen by EDS that cleared under K960889 used Titanium Nitride as plating materials. - The proposed device is manufactured by sintering while the predicate device is machined. The end result ● from either method are ultrasonic tips with similar geometries and identical intended uses. The different manufacturing methods simply reflect the in-house equipment / manufacturing capabilities of the two different companies and do not affect the overall safety or performance of the device. - . The proposed device uses a Chromium:Nickel:Copper stainless steel alloy, while the predicate device uses a Chromium:Nickel:Molybdenum stainless steel. The materials were chosen based on the manufacturing methods and do not affect the overall safety or performance of the device. - The proposed device offers 6 variants; the predicate device offers 6 variants, but there isn't an exact 1:1 matchup and the overall sizes and weights are slightly different. However, these differences do not raise any new questions of safety or effectiveness. The minor differences between the ultrasonic tips under review and the predicate device cleared under K132609 are as follows: - The proposed device consistently references the ISO standard for thread sizes to interface with the ultrasonic ● generators (M3x0.5 or M3x0.6 thread), while the predicate device references one ISO and one American standard (M3x0.5 and #5-40 thread). - The proposed device explicitly states the intended users, the intended use environment, the targeted patient . population, the operating & storage temperatures, compliance to specific standards, etc. while the predicate device does not. The proposed device states that they are to be "used on piezo ultrasonic endodontic and scaler units which operate in the range of 20,000hz - 35,000hz," while the predicate device states that they vibrate "at high frequencies (up to 40,000 Hz)." A table showing substantial equivalence to the predicate device follows: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the words "engineered endodontics" in green font. The word "engineered" is on the top line, and the word "endodontics" is on the bottom line. The words are in a sans-serif font and are outlined in a light gray color. There is a registered trademark symbol to the right of the word "endodontics". #### tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY Volume 2 Section 3 | | Proposed Device: tün® ultrasonic tips<br>Product Family | Predicate Device: EDS Ultrasonic Tips<br>K132609 | | |-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | | | Comments | | COMPARISON OF GENERAL INFORMATION / USES & INDICATIONS | | | | | Photograph | Image: tün® ultrasonic tips | Image: EDS Ultrasonic Tips | For Information Purposes only, but the images show<br>that the Proposed Device is Substantially Equivalent<br>in its overall shape/configurations to the predicate<br>device. | | FDA Product Code | ELC | ELC | Identical to the predicate.<br>Therefore, Substantially Equivalent | | FDA Regulation Number | 872.4950 | 872.4950 | Identical to the predicate.<br>Therefore, Substantially Equivalent | | FDA Regulation Class | Class II | Class II | Identical to the predicate.<br>Therefore, Substantially Equivalent | | FDA Regulation<br>Description | Scaler, Ultrasonic | Scaler, Ultrasonic | Identical to the predicate.<br>Therefore, Substantially Equivalent | | Intended Use /<br>Indication for Use<br>(As statement appears in the<br>510(k) indications for use<br>form) | tün® ultrasonic tips are intended for use by dental<br>professionals for the removal of soft and hard tissue<br>during endodontic root canal preparation procedures.<br>They can also aid in the removal of endodontic posts and<br>other intra-canal blockages. | EDS Ultrasonic Tips are intended for use by dental<br>professionals for the removal of soft and hard tissue during<br>endodontic root canal preparation procedures. They can<br>also aid in the removal of endodontic posts and other intra-<br>canal blockages. | Except for branding issues (tün® versus EDS), the<br>Indication for Use statements are identical. Branding<br>does not raise any new questions of safety of<br>effectiveness.<br>Therefore, Substantially Equivalent | | FDA Device Description<br>(As it appears in the<br>applicable FDA Summary<br>Statement) | tün® ultrasonic tips are an accessory to a piezoelectric<br>ultrasonic handpiece and scaler unit. These powered<br>components are not included as part of the device<br>submitted for application with the 510(k) submission.<br>tün® ultrasonic tips are stainless steel and will be<br>available in M3x0.5 and M3x0.6 thread with 6 different<br>tip designs. 1 tip design is devised for post removal; the<br>remaining 5 tips are designed for negotiating the various<br>angles and directions of root canals. | EDS Ultrasonic Tips are an accessory to a piezoelectric<br>ultrasonic handpiece and scaler unit. These powered<br>components are not included as part of the device<br>submitted for application with the 510(k) submission. EDS<br>Ultrasonic Tips are stainless steel and will be available in<br>M3x0.5 and #5-40 thread with 6 different tip designs. 1 tip<br>design is devised for post removal; the remaining 5 tips are<br>designed for negotiating the various angles and directions<br>of root canals. | Except for branding issues (tün® versus EDS), and<br>the use of thread standards (M3x0.6 vs #5-40), the<br>Device Descriptions are identical. The proposed<br>device consistently references the ISO standard for<br>thread sizes, while the predicate device references one<br>ISO and one American standard). Branding issues and<br>citing different but equivalent standards for thread<br>sizes do not raise any new questions of safety of<br>effectiveness.<br>Therefore, Substantially Equivalent | | Intended User(s) | Dentists, Endodontists, Oral surgeons, and Dental<br>hygienists | Although not formally stated, assumed to be Dentists,<br>Endodontists, Oral surgeons, and Dental hygienists | Although not known to be formally stated in the<br>predicate's submission, the intended users are<br>assumed to be identical to the predicate. | | | Proposed Device: tün® ultrasonic tips<br>Product Family | Predicate Device: EDS Ultrasonic Tips<br>K132609 | | | Item | | | Comments | | Intended Use<br>Environment | In dental clinics | Although not formally stated, assumed to be dental clinics | Therefore, Substantially Equivalent<br>Although not known to be formally stated in the<br>predicate's submission, the Intended Use Environment<br>is assumed to be identical to the predicate.<br>Therefore, Substantially Equivalent | | Contra-Indication(s) | There are no known contra-indications when used as<br>recommended. | There are no known contra-indications when used as<br>recommended. | Identical to the predicate.<br>Therefore, Substantially Equivalent | | Warnings | Please refer to the instructions for use of the manufacturer of<br>the piezoelectric ultrasonic unit. It is important to note that<br>the different | Please refer to the instructions for use of the manufacturer of<br>the piezoelectric ultrasonic unit. It is important to note that the<br>different | Identical to the predicate.<br>Therefore, Substantially Equivalent | | Precautions | • Do not start the piezoelectric ultrasonic generator with<br>damaged ultrasonic tips.<br>• For best results, and your safety, the use of a visual<br>aid is recommended.<br>• Do not heat above 275°F/135°C.<br>• Tips that have been distorted in any fashion should be<br>discarded.<br>• To avoid overheating the dentin structures, do not<br>apply continuous contact for more than 30 seconds.<br>• The tip must be tightened onto the ultrasonic handpiece<br>prior to use. Please pay attention not to over tighten nor<br>under tighten. | • Do not start the piezoelectric ultrasonic generator with<br>damaged ultrasonic tips.<br>• For best results, and your safety, the use of a visual aid is<br>recommended.<br>• Do not heat above 275°F/135°C.<br>• Tips that have been distorted in any fashion should be<br>discarded.<br>• To avoid overheating the dentin structures, do not apply<br>continuous contact for more than 30 seconds.<br>• The tip must be tightened onto the ultrasonic handpiece<br>prior to use. Please pay attention not to over tighten nor<br>under tighten. | Identical to the predicate.<br>Therefore, Substantially Equivalent | | | | COMPARISON OF STERILIZATION ISSUES | | | Sterilization Status | Provided non-sterile. | Provided non-sterile. | Identical Sterilization Status.<br>Therefore, Substantially Equivalent | | Sterilization Instructions | tün ultrasonic tips are not sold sterile and must be<br>cleaned and sterilized prior to each use.<br>A. Wipe tips with a cleaning disinfectant.<br>B. Cleaning -<br>Pre-clean using a high-quality, pH neutral, ultrasonic<br>cleaning solution. Follow solution manufacturer's<br>instructions.<br>Dry thoroughly with a towel and compressed air.<br>C. Steam Sterilization -<br>Place the tips to be sterilized in an autoclave pouch<br>prior to sterilization. | EDS Ultrasonic Tips are not sold sterile and must be<br>cleaned and sterilized prior to each use.<br>A. Wipe tips with a cleaning disinfectant.<br>B. Cleaning -<br>Pre-clean using a high-quality, pH neutral, ultrasonic<br>cleaning solution. Follow solution manufacturer's<br>instructions.<br>Dry thoroughly with a towel and compressed air.<br>C. Steam Sterilization -<br>Place the tips to be sterilized in an autoclave pouch<br>prior to sterilization. | Except for branding issues (tün® versus EDS), the<br>Sterilization Instructions are identical. Branding does<br>not raise any new questions of safety of effectiveness.<br>Therefore, Substantially Equivalent | | Sterilization Parameters | Gravity Steam Sterilizer:<br>• Temperature: 250° F/121° C.<br>• Cycle Time: 30 minutes<br>• Maximum Dry Time: 30 minutes<br>Prevacuum Steam Sterilizer: | Gravity Steam Sterilizer:<br>• Temperature: 250° F/121° C.<br>• Cycle Time: 30 minutes<br>• Maximum Dry Time: 30 minutes<br>Prevacuum Steam Sterilizer: | Identical Sterilization Parameters.<br>Therefore, Substantially Equivalent | VOL 002/009 VOL 002 003 Traditional 510(k) Summary - REVISED 2.docx tün® ultrasonic tips Product Family Traditional 510(k) Submission Confidential Page 002/003-3 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the words "engineered endodontics" in green font. The word "engineered" is on the top line, and the word "endodontics" is on the bottom line. There is a registered trademark symbol to the right of the word "endodontics". The background is white. # tün® ultrasonic tips Volume 2 Section 3 | tün® ultrasonic tips Product Family<br>Traditional 510(k) Submission | Confidential | VOL 002/009 VOL 002 003 Traditional 510(k) Summary - REVISED 2.docx<br>Page 002/003-4 | |----------------------------------------------------------------------|--------------|---------------------------------------------------------------------------------------| |----------------------------------------------------------------------|--------------|---------------------------------------------------------------------------------------| {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the words "engineered endodontics" in a stylized font. The words are stacked on top of each other, with "engineered" on the top line and "endodontics" on the bottom line. The text is green with a light gray outline. There is a registered trademark symbol next to the word "endodontics". # tün® ultrasonic tips Volume 2 Section 3 | | Proposed Device: tün® ultrasonic tips<br>Product Family | | | Predicate Device: EDS Ultrasonic Tips<br>K132609 | | Comments | |--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | • Temperature: 270° F/132° C. | | | • Temperature: 270° F/132° C. | | | | | • Cycle Time: 4 minutes | | | • Cycle Time: 4 minutes | | | | | • Maximum Dry Time: 30 minutes | | | • Maximum Dry Time: 30 minutes | | | | | | | | | | | | Operating Principle | tün tips interact with piezo ultrasonic hand piece and<br>unit. tün tips are an accessory to a piezo ultrasonic hand<br>piece and unit.<br>tün tips are used on piezo ultrasonic endodontic and<br>scaler units which operate in the range of 20,000hz –<br>35,000hz. | | COMPARISON OF OPERATING PRINCIPLES & MATERIALS<br>Used in conjunction with piezoelectric ultrasonic handpiece<br>and scaler. Ultrasonic energy vibrates tip at high<br>frequencies (up to 40,000 Hz) | | | Identical Operating Principles with similar operational<br>ranges.<br>Therefore, Substantially Equivalent | | Comparison of Tip Shapes | Tip<br>Shape<br>E1 Radiused Tip with diamond<br>E2 Radiused Tip without diamond<br>E3 Ball Tip<br>E4 Football Tip<br>E5 Disc-Shaped Tip<br>E6 Short, Robust Tip | EDS Tip<br>EDS 2/3<br>EDS 2/3<br>EDS 4<br>EDS 4<br>EDS 5<br>EDS 1 | Tip<br>EDS 1<br>EDS 2<br>EDS 3<br>EDS 4<br>EDS 5<br>EDS 6<br>Equivalent | Shape<br>Short, Robust Tip<br>Radiused Tip<br>Radiused Tip II<br>Large Point Tip<br>Small Pointed Tip<br>N/A - Irrigation Tip | tün Tip<br>E6<br>E1/2<br>E1/2<br>E3/4/5<br>E1/2<br>No Direct | Both the predicate device and the proposed device<br>offer the various tip shapes that are commonly used in<br>the industry. The differences in tip shape do not<br>introduce any new questions of safety or<br>effectiveness.<br>Therefore, Substantially Equivalent | | Construction Materials | 17-4ph Stainless Steel<br>Alloy 17-4PH (UNS S17400), Type 630, is a chromium-<br>nickel-copper precipitation-hardening martensitic<br>stainless steel with an addition of niobium. 17-4PH<br>combines high strength and hardness with good<br>corrosion resistance. | | 316 Stainless Steel<br>Alloy 316/316L (UNS S31600/ S31603) is a chromium-<br>nickel- molybdenum austenitic stainless steel developed to<br>provide improved corrosion resistance to Alloy 304/304L<br>in moderately corrosive environments. It is often utilized in<br>process streams containing chlorides or halides. The<br>addition of molybdenum improves general corrosion and<br>chloride pitting resistance. It also provides higher creep,<br>stress-to-rupture and tensile strength at elevated<br>temperatures. | | | The proposed device uses a Chromium:Nickel:<br>Copper stainless steel alloy, while the predicate device<br>uses a Chromium:Nickel:Molybdenum stainless steel<br>alloy. The difference in materials reflect different<br>manufacturing methods (sintering versus machining)<br>and does not affect the overall safety or performance<br>of the finished device.<br>Therefore, Substantially Equivalent | | Coatings | Nickel Plating or<br>Diamond Nickel Plating | | None | | | The proposed device is plated while the predicate<br>device is not. This difference is a function<br>manufacturing method and does not affect the overall<br>safety or performance of the device. Note: The<br>predicate device chosen by K132609 used<br>Titanium Nitride and Zirconium Nitride as plating<br>materials - see K960889.<br>Therefore, Substantially Equivalent | | | | | | COMPARISON OF CLINICAL USE / INTERACTIONS WITH OTHER DEVICES | | | | Interaction with other<br>products and/or items<br>used with the product | tün instruments have been designed to function on most<br>brands of Piezo-Electric type dental ultrasonic Scalers<br>that use an M3x0.5 or M3x0.6 thread. Refer to your | | | EDS Ultrasonic Tips are an accessory to a piezoelectric<br>ultrasonic handpiece and scaler unit with M3x0.5 or #5-40<br>threads | | Both devices require the use of third-party ultrasonic<br>scalers. These devices use one of two thread types<br>either M3x0.5 or M3x0.6/#5-40. Functionally, the | | tün® ultrasonic tips Product Family | VOL_002/009 VOL_002_003_Traditional 510(k) Summary - REVISED 2.docx | | |-------------------------------------|---------------------------------------------------------------------|----------------| | Traditional 510(k) Submission | Confidential | Page 002/003-5 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the words "engineered endodontics" stacked on top of each other. The words are in a green sans-serif font with a light gray outline. The word "engineered" is on top, and the word "endodontics" is below it. There is a registered trademark symbol to the right of the word "endodontics". ### tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY Volume 2 Section 3 | Item | Proposed Device: tün® ultrasonic tips<br>Product Family | Predicate Device: EDS Ultrasonic Tips<br>K132609 | Comments | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ultrasonic machine owner's manual for further details on<br>the use of these types of devices. | | devices are same.<br>Therefore, Substantially Equivalent | | COMPARISON OF PACKAGING SPECIFICATIONS / CONFIGURATIONS | | | | | Catalog Numbering | The catalog number schema uniquely identifies each<br>variant as tun-e-X or tun-e-Xe<br>Where e-X = Satelec type threads and X = the tip style<br>from 1 to 6<br>And e-Xe = EMS type threads and X = the tip style from<br>1 to 6. | The catalog number schema uniquely identifies each<br>variant as 610-XX or 615-XX<br>Where 610 = E type threads; 615 = M type threads<br>And XX = the tip style from 01 to 06.<br>Image: 610-xx E-Threads Fit These Units:<br>Image: 615-xx M-Threads Fit These Units: | Both the proposed and predicate devices offer a total<br>series of 6 tips that use two different thread styles for<br>a total of 12 different tips. The proposed devices call<br>M3x0.6 threads "Satelec" style, while the predicate<br>calls them "E" style and proposed devices calls<br>M3x0.5 threads "E" style, while the predicate calls<br>them "M" style. Both devices use a formulaic catalog<br>numbering system to encode for the 12 variants.<br>Although the systems are different, no new issues of<br>safety or effectiveness are introduced.<br>Therefore, Substantially Equivalent | | Packaging Configurations | Sold as individual tips | Sold as individual tips | Identical to the predicate.<br>Therefore, Substantially Equivalent | | Packaging Materials | Plastic tray…