Highspeed Airturbine Handpiece

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. November 8, 2021 Beijing Dongbo Dental Handpiece Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai, 200120 CHINA Re: K202371 Trade/Device Name: Highspeed Airturbine Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: August 5, 2021 Received: August 10, 2021 Dear Diana Hong: 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. 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 {1}------------------------------------------------ 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 (OS) 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 mediation-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, Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices 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) K202371 Device Name Highspeed Airturbine Handpiece Indications for Use (Describe) This Highspeed Airturbine Handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures It is designed for use by a trained professional in the field of general dentistry. Type of Use (Select one or both, as applicable) | | Prescription Use (Part 21 CFR 801 Subpart D) | |--|----------------------------------------------| | | Over-The-Counter Use (21 CFR 801 Subpart C) | ## 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}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K202371 - 1. Date of Preparation: November 7, 2021 - 2. Sponsor Identification ## Beijing Dongbo Dental Handpiece Co., Ltd. 3F, Building 3, No. 17, First Jinmayuan Street, Shunyi District, Beijing, China Establishment Registration Number: 3515005486 Contact Person: Chao Hao Position: Administration office Tel: +86-10-80479758 Fax: +86-10-80478329 Email: haochao123459@126.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (Alternative Contact Person) ## Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ - 4. Identification of Proposed Device Trade Name: Highspeed Airturbine Handpiece Common Name: Handpiece, Air-powered, Dental Regulatory Information Classification Name: Dental Handpiece and Accessories Classification: I; Product Code: EFB; Regulation Number: 21CFR 872.4200 Review Panel: Dental #### Indication for Use: This Highspeed Airturbine Handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures It is designed for use by a trained professional in the field of general dentistry. ### Device Description The Highspeed Airturbine Handpiece is air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the pre-vacuum Autoclave methods. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine. - ર. Identification of Predicate Device Predicate device 510(k) Number: K141576 Product Name: Maxima PRO 45L Reference device 510(k) Number: K172543 Product Name: High-speed Turbine Handpieces for Single Use - 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: {5}------------------------------------------------ - > ISO 10993-5: 2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity - > ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization - > ISO 9168:2009 Dentistry - Hose Connectors For Air Driven Dental Handpieces - > ISO 14457:2012 Dentistry - Handpieces And Motors - > ASTM D4169:2016 Standard Practice For Performance Testing Of Shipping Containers And Systems - > Guidance for Industry and FDA Staff- Dental Handpieces- Premarket Notification [510(k)] Submissions - > Cleaning and Sterilization Validation per the FDA Reprocessing Guidance Document - 7. Clinical Test Conclusion No clinical study is included in this submission. {6}------------------------------------------------ #### 8. Substantially Equivalent (SE) Comparison | ITEM | Proposed Device | Predicate Device | Reference Device | Remark | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | | | K141576 | K172543 | | | Product Code | EFB | EFB | EFB | Same | | Classification | Class I | Class I | Class I | Same | | Regulation<br>Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | Same | | Indication for<br>use | This Highspeed Airturbine<br>Handpiece is intended for<br>removal of carious<br>material, cavities and crow<br>preparations, removal of<br>filings, processing of tooth,<br>restoration of surfaces and<br>as a surgical tool for third<br>molar removal procedures<br>It is designed for use by a<br>trained professional in the<br>field of general dentistry. | This air-powered dental<br>handpiece is intended for<br>removal of carious material,<br>cavities and crow<br>preparations, removal of<br>filings, processing of tooth,<br>restoration of surfaces and as<br>a surgical tool for third molar<br>removal procedures<br>It is designed for use by a<br>trained professional in the<br>field of general dentistry. | High-speed Turbine<br>Handpieces for Single Use<br>are intended for removing<br>carious material, excess<br>filling material, cavity and<br>crown preparation, finishing<br>tooth preparations and<br>restorations, root canal<br>preparations and polishing<br>teeth. | Same | | Principle of<br>operation | Air power | Air power | Air power | Same | | Patient-contact<br>material | Brass<br>Aluminum | Round Copper<br>Cr-N/Cr Coating<br>Round Steel<br>Cr Coating<br>Ecobrass | Brass<br>Aluminum<br>ABS | Different | | Air/water<br>spray | water | water | Water | Same | | Water cooling | Yes | Yes | Yes | Same | | Fiber optics | With/without light | With light | Without light | Different | | Type of chuck | Push Button | Push Button | Push Button | Same | | Light intensity | More than 7000 LUX | Approx. 25,000 LUX | NA | Different | | Type<br>of<br>connectors | Hose connection | Hose connection | Hose connection | Same | | Speed in rpms | 350,000; 380,000; 480,000<br>rpm | 380,000~420,000 rpm | 350,000; 380,000rpm | Different | | Bur retention<br>force (N cm) | 22~45 | Up to 24 | >22N/<br>22~45N | SE | | Head<br>diameter(mm) | 12.5, 11, 9.5 | 12.5 | Unknown | Different | | Operating<br>Pressure | 245Kpa (~35.53psi) | 40psi | 245Kpa | Same | | Head angle | 18 and 45 degree | 45 degree | 18 and 45 degree | Same | | Single<br>use/Reuse | Reuse | Reuse | Single-use | Same | | Sterilization | Autoclave sterilization | Gravity steam autoclave | Radiation | Different | | Cytotoxicity | Biocompatibility | No Cytotoxicity | No Cytotoxicity | Different | | Intracutaneous<br>Reactivity | demonstrated by K172543 | No Intracutaneous Reactivity | No Intracutaneous Reactivity | | | Skin<br>Sensitization | | No Skin Sensitization | No Skin Sensitization | | | Performance | Compliance with ISO<br>14457:2012 and ISO<br>9168:2009 | Compliance with ISO<br>14457:2012 and ISO<br>9168:2009 | Compliance with ISO<br>14457:2012 and ISO<br>9168:2009 | Same | ## Table 1 Comparison of Technology Characteristics 4 / 6 {7}------------------------------------------------ ## Different- Patient-contact material The patient-contact materials of the proposed device are different from the predicate devices, but the brass and aluminum of the proposed device is the same as the brass and aluminum of reference device, which is also manufactured by Beijing Dongbo Dental Handpiece Co., Ltd. The biocompatibility test has been conducted on the K172543 and the test result comply with the requirements of ISO 10993. Therefore, the different will not affect the safety and effectiveness of the proposed device ## Different- Fiber optics The fiber optics of the proposed device are different from the predicate device or reference device. The proposed device contains handpieces with and without lighting function. However, the predicate device is handpieces with light and the reference device is handpieces without light. Therefore, the fiber optics (with/without light) will not affect the safety and effectiveness of the proposed device. #### Different- Light intensity The light intensity of the proposed device is different from the predicate device. However, the light intensity of the proposed device meet the requirement of ISO 14457. And the proposed device shall be operated by trained healthcare professions. Therefore, the different will not affect the safety and effectiveness of the proposed device. Therefore, the different will not affect the safety and effectiveness of the proposed device. ## Different- Speed in rpms The speeds of the proposed device are different from the predicate device. The 480,000rpm are out range of the predicate device. The different speeds will be selected by physician per patients' condition. {8}------------------------------------------------ In addition, the performance test has been conducted on proposed device according to ISO 14457 and the test results meet the acceptable criteria. Therefore, the different will not affect the safety and effectiveness of the proposed device. ## Different- Head diameter The head diameter of the proposed device is different from the predicate device. The 11mm and 9.5mm are out range of the predicate device. However, the difference is just in physical specification and different specification will be selected by physician per patients' condition. Therefore, the different will not affect the safety and effectiveness of the proposed device. ## Different- Sterilization The steam sterilization method of the proposed device are different with the predicate device. However, the sterilization parameters comply with ISO 17665 standard. Therefore, the difference will not affect the safety and effectiveness of the proposed device. ## Different- Biocompatibility The patient-contact materials of the Highspeed Airturbine Handpiece are identical device to that of the legally marketed device, High-speed Turbine Handpieces for Single Use, as cleared in K172543, which is also manufactured by Beijing Dongbo Dental Handpiece Co., Ltd. Therefore, the biocompatibility for proposed device is demonstrated by reference device (K172543). The biocompatibility testing for K172543 was evaluated and the tests results complied with ISO 10993 standards. Therefore, the patient-contact materials of the proposed device will not have the adverse effects on patients. Therefore, this difference does not affect the safety and effectiveness of the proposed device. #### 9. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.