EVO 450 series High Speed Handpieces

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 11, 2019 Ttbio Corp. Shu-Ching Lee Section Chief 2F, No.7, 6th Road Industry Park Taichung, 40755 TAIWAN Re: K190508 Trade/Device Name: EVO 450 series High Speed Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: November 11, 2019 Received: November 13, 2019 Dear Shu-Ching Lee: 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 {1}------------------------------------------------ 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 Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K190508 Device Name EVO 450 series High speed Handpieces Indications for Use (Describe) The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures. Type of Use (Select one or both, as applicable) | <div> <span style="font-size:14px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------| | <div> <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" letters connected together, followed by the word "BIO" in a simple sans-serif font. The entire logo is in a light gray color. The logo appears to be for a biotechnology company. TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196 # 510(K) SUMMARY-K190508 EVO 450 series High Speed Handpieces - 1. Date Prepared: December 10,2019 2. Submitter Information 510(k) Owner: TTBIO CORP. 2F, No.7, 6th Road, Industry Park, Taichung, Taiwan, R.O.C. 40755 Contact Person: Shu-Ching Lee/Section Chief Phone: 886-4-23595958/email: jo@ttbio.com - 3. Device Name Trade Name: EVO 450 series High Speed Handpieces Common Name: Dental Handpiece Classification Name: Dental Handpiece and Accessories (21 CFR 872.4200, Product Code EFB) - 4. Predicate Device: Maxima PRO2 45L made by Kaltenbach & Voigt GmbH (K141576) - 5. Device Description: The EVO 450 series High Speed Handpieces are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. Others could be connected to hose connectors type 2 or type 3 according to ISO 9168:2009 Dental handpieces-Hose connectors for air driven dental handpieces. The EVO 450 series High Speed Handpieces will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. For proper operation, make sure that the supply of cooling air is dry, clean and uncontaminated. Make sure that air is not emitted in the direction of the bur. After each patient use, disinfect the tubing waterlines including the handpiece waterlines by flushing with cleaning water to prevent cross-contamination according to handpiece waterlines disinfection procedure of main dental unit. {4}------------------------------------------------ TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196 Further one there is a nozzle cleaner needle supplied with the EVO 450 series High Speed Handpiece. If spray nozzle is blocked with debris clean the spray nozzle with the nozzle cleaner needle. - 6. Intended Use: The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures. - 7. Substantial Equivalence The EVO 450 series High Speed Handpieces are the same as predicate device, Air-Powered handpieces, which intended for dentistry treatment and these devices are only for trained persons in the field of dentistry. The proposed devices are essentially identical or similar to the predicate device in terms of the design, principles of operation, technological characteristics and materials. The patient contact materials used are well-known biocompatible, so no new issues of biocompatibility are raised with regard to the proposed devices. Additionally, the proposed devices are complying with FDA recognized standards for High-Speed dental handpieces. | Summary Table of Substantial Equivalence | | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Descriptive<br>Information | Proposed Device | Predicate Device | | | EVO 450 series | Maxima PRO2 45L<br>(K141576) | | Indication for<br>use | The EVO 450 series is the air-powered<br>dental handpiece which is used by<br>trained dental professionals for<br>removal of carious material, cavities,<br>crown preparations and as a surgical<br>tool for impacted third molar removal<br>and periodontal procedures. | This air-powered dental handpiece is<br>intended for removal of carious<br>material, cavities and crow<br>preparations, removal of filings,<br>processing of tooth, restoration of<br>surfaces and as a surgical tool for<br>third molar removal procedures. | | Principle of<br>operation | The coupling through the tube<br>connected to a dental unit. The<br>devices receive the air for the turbine<br>to proceed the system used<br>air-powered technique. The cooling<br>water for cutting treatment. And parts<br>of devices have a light system for<br>illumination the operation area. | Through the tube and the coupling<br>connected to a dental unit, the<br>air-powered handpiece receives the<br>air for operating the high speed<br>turbine, the cooling water for cutting<br>treatment through one port and light<br>for illumination the operation area. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for a company called "TBIO". The logo consists of two stylized "T" shapes that are connected to the word "BIO". The logo is gray and has a modern, minimalist design. The logo is likely used to represent the company's brand and identity. ### TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196 | Summary Table of Substantial Equivalence | | | |--------------------------------------------|-----------------------------------------------------------------|---------------------------------| | Descriptive<br>Information | Proposed Device | Predicate Device | | | EVO 450 series | Maxima PRO2 45L<br>(K141576) | | Water ports | Four | One | | Fiber optics | With and without fiber-optic glass rod<br>built-in light system | With built-in light system | | Light intensity<br>on input side | N/A | Approx. 25000 Lux | | Head<br>Dimensions | Φ10.5×H12.5mm | Φ12.5×H14.6mm | | Type of chuck | Push button locking chuck | Identical | | Materials of<br>body of the<br>device | Stainless steel | Stainless steel | | Bur retention<br>force | Up to 24 N-cm | Identical | | Operation<br>pressure | 2.0-3.0 bar | 2.75±0.1 bar | | Speed | 360,000~440,000 rpm | 380,000~420,000 rpm | | Conformance with<br>standards for<br>shank | Ø1.59mm~1.60 mm | Identical | | Head angle | 45-degree | Identical | | Compliance to<br>Standards | ISO 14457:2017<br>ISO 9168:2009 | ISO 14457:2012<br>ISO 9168:2009 | | Sterilization<br>Method | Steam Autoclave (Moist Heat) | Steam Autoclave (Moist Heat) | | Sterilization<br>Standard | ISO 17665-1:2006 | ISO 17665-1:2006 | - 8. Discussion of non-clinical data: The functions of EVO 450 series High Speed Handpieces were verified according to ISO14457:2017. Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products – moist heat – Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff -Processing/Reprocessing Medical Devices in Health Care Settings. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" shapes that are connected to each other. To the right of the second "T" is the word "BIO" in a simple sans-serif font. The entire logo is in a light gray color. TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196 - 9. Discussion of Clinical Tests Performed: N/A - 10. Conclusion: The EVO 450 series High Speed Handpieces are substantially equivalent to the predicate device. They are same as the predicate device in terms of its intended use, operating principles and functions.