Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 12, 2026 Foshan Topmed Dental Co., Ltd % Salon Chen System Engineer IMD Medical & Drug technology service institutions System engineer Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District Dongguan, Guangdong 523932 China Re: K251388 Trade/Device Name: Dental air-motor handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB, EGS Dated: December 15, 2025 Received: December 15, 2025 Dear Salon Chen: 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 (the 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 available 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} K251388 - Salon Chen Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K251388 - Salon Chen Page 3 assistance/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,  Bobak Shirmohammadi -S For Michael E. Adjodha, MChE, RAC, CQIA 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 {3} Dental air motor handpiece Page 8 of 28 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251388 | ? | | Please provide the device trade name(s). | | ? | | Dental air motor handpiece (TM-203B2、TM-203M4、TM-205B2、TM-205M4、TM-IS、TM-ES、 TM-SG20、TM-X25、TM-BB、TM-IC、TM-RA41) | | | | Please provide your Indications for Use below. | | ? | | Dental air motor handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K251388 - 510(k) Summary 1. Submitter's Identification: - Company Name: Foshan Topmed Dental Co., Ltd - Address: Room 401, Floor 4, Block C, No.7, Gui dan road side section, Luo cun Street, Shi shan Nanhai District, Foshan City - Phone: +86-757-81803362 - Fax: +86-757-81803362 - Contact Person (Title): Liang Guo chan (General Manager) - E-mail: TOPMED03 @TOPMEDDDENTAL.COM - Date of Preparation: January 7, 2026 2. Common Name and Classification: - Device Classification Name: Dental Handpiece and accessories - Classification Product Code: EFB、EGS - Regulation Number: 21CFR 872.4200 - Class: 1 - Review Panel: Dental - Device Name: Dental air motor handpiece - Model: TM-203B2、TM-203M4、TM-205B2、TM-205M4、TM-IS、TM-ES、TM-SG20、TM-X25、TM-BB、TM-IC、TM-RA41 3. Predicate Device 1 Information: - 510(k) Number: K170236 - Device Classification Name: Dental - Sponsor: Guangdong JINME Medical Technology Co., Ltd. - Classification Product Code: EFB、EGS - Regulation Number: 21CFR 872.4200 - Class: 1 - Review Panel: Dental Page 1 {5} Page 2 - Trade/Proprietary Name: Dental Low-speed Turbine Handpiece - Common Name: Dental Handpiece ## 4. Predicate Device 2 Information: - 510(k) Number: K150798 - Device Classification Name: Dental - Sponsor: Codent Technical Industry Co., Ltd. - Classification Product Code: EFB、EGS - Regulation Number: 21CFR 872.4200 - Class: 1 - Review Panel: Dental - Trade/Proprietary Name: Codent Low Speed Dental Handpieces and Accessories - Common Name: Dental Handpiece ## 5. Predicate Device 3 Information: - 510(k) Number: K141886 - Device Classification Name: Dental - Sponsor: MODERN KOREA Co., Ltd. - Classification Product Code: EFB - Regulation Number: 21CFR 872.4200 - Class: 1 - Review Panel: Dental - Trade/Proprietary Name: MDK low-speed handpieces - Common Name: Dental Handpiece ## 6. Application Correspondent - Company Name: IMD Medical & Drug technology service institutions - Phone: +86-18613190779 - Fax: +86-755-62809168 - Contact Person (Title): Salon Chen (System engineer) - E-mail: 33999439@qq.com - Address: Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, {6} Guangdong Province, China ## 7. Device Description Dental air motor handpiece is an instrument for drilling, grinding, repairing teeth that is utilized in dental clinics. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece. The subject device consists of 11 model variations: TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41. The device description of Dental air motor handpiece is as follows: The gear ratios of handpieces have various gear ratios (for different geared angle handpiece); - Handpiece and adaptors can bear steam - The gear ratios of handpieces have a various gear ratio (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 4:1 (speed reduction)); - The handpieces have maximum Forward rotation speed 24000rpm and maximum Reverse rotation speed of 24000 rpm. The air motors are capable of running up to a speed of 24000 rpm, but can vary at different pressure of air supply. Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into two types. It included 2-hole (drive air and water holes) and 4-hole coupling (drive air, exhaust air, spray air and spray water holes). The use of the coupling of handpiece is due to the number of tubes of dental unit. The subject device is intended to be used for dental professional use only. In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483). ## 8. Indications for Use Dental air motor handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Page 3 {7} 9. Comparison to the predicate device Table 1 General Comparison | Elements of Comparison | Proposed Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Judgment | | --- | --- | --- | --- | --- | --- | | Company Name | Foshan Topmed Dental Co., Ltd | Guangdong JINME Medical Technology Co., Ltd. | Codent Technical Industry Co., Ltd. | MODERN KOREA Co., Ltd. | / | | Device Name | Dental air motor handpiece | Dental Low-speed Turbine Handpiece | Codent Low Speed Dental Handpieces and Accessories | MDK handpieces - Low-speed handpieces | / | | Classification Product Code | EFB、EGS | EFB、EGS | EFB、EGS | EFB | Similar | | Regulation | 21CFR 872.4200 | 21CFR 872.4200 | 21CFR 872.4200 | 21CFR 872.4200 | Same | | Classification Name | Dental | Dental | Dental | Dental | Same | | Class | 1 | 1 | 1 | 1 | Same | | Prescription or OTC | Prescription Use | Prescription Use | Prescription Use | Prescription Use | Same | Page 4 {8} Table 2 Safety factor & Performance Comparison | Safety factor & Performance | Proposed Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Judgment | | --- | --- | --- | --- | --- | --- | | Operational Modes | Air-powered | Air-powered | Air-powered | Air-powered | Same | | Type of Chunk | Push button, Wrench, Screw, Tip-lock chuck options | Push button Latch-type chuck | Push button | Push button, latch, screw, snap-on or tip-lock chuck options | Analysis 1 | | Composition of Main Materials | Stainless Steel, Brass | Stainless Steel, Brass, Titanium | Stainless Steel, Brass, Titanium | Stainless Steel, Brass, Titanium | Analysis 2 | | Operating Pressure | 0.20-0.30Mpa | 245 ~ 392 KPa | --- | 36psi to 43 psi | Analysis 3 | | Motor Speed | 17000 rpm ~24000 rpm | 18,000 ~ 22,000 rpm | 25,000rpm | Up to 20,000 rpm | Analysis 3 | {9} | Safety factor & Performance | Proposed Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Judgment | | --- | --- | --- | --- | --- | --- | | Sterilization | Steam autoclave method | Steam autoclave method | | | Same | | Compliance Standards | Complied with ISO 10993-5, ISO 10993-10, ISO14457 | Complied with ISO 10993-5, ISO 10993-10, ISO14457 | -- | Complied with ISO 10993-5, ISO 10993-10, ISO14457 | Same | | Lubricant | The specified lubricant, type “PANA SPRAY Plus” manufactured by NAKANISHI INC (Cleared in K163483), must be used during routine maintenance. | The specified lubricant, type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483), must be used during routine maintenance. | -- | Pana-Spray made by NSK(K052700) | Similar | ## Review of Differences ### Analysis 1 The proposed device is different in Chuck from the predicate device. However, the difference does not affect the substantial equivalence between the proposed device and predicate devices. Based on the nonclinical tests performed, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device. Page 6 {10} Page 7 # Analysis 2 The main materials of the subject device are different from those in the predicate devices. However, the subject and predicate devices follow ISO 10993-1. The subject device was tested in accordance with the methods outlined in ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021. These tests were selected on characterization of the components in accordance with ISO 10993-1:2018 (Mucosal membrane device, surface contacting, limited contact duration (<24 hours)). # Analysis 3 Although the subject device is different from the predicate devices in Operating Pressure and Motor Speed, the subject device conforms with ISO 14457:2017 Dentistry -Handpieces and Motors. The difference in operating pressure and motor speed will not affect substantial equivalence between the subject and predicate devices. ## 10. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows: A series of 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. 1) **Basic Safety and Essential Performance** Performance test according to ISO 14457:2017 2) **Biocompatibility testing** ISO 10993-1:2018 Biological evaluation of medical devices - Parts 1: Evaluation and testing. ISO 10993-5:2019 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2021 Biological evaluation of medical devices - Parts 10: Tests for skin sensitization {11} ISO 10993-11:2017 Biological evaluation of medical devices, Part 11: Tests for systemic toxicity ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation. All the test results demonstrate that the subject device, Dental air motor handpiece meets the requirements of its pre-defined acceptance criteria and intended uses and is substantially equivalent to the predicate device. ## 11. Clinical Tests Performed No clinical test data was used to support the decision of substantial equivalence. ## 12. Conclusion The subject devices have all features of the predicate devices. The few differences were evaluated and do not affect the safety and effectiveness of the subject devices compared to the predicate. Thus, the subject devices are substantially equivalent to the predicate devices. Page 8