510(k) K251389

Device: High speed air turbine handpiece
Applicant: Foshan Topmed Dental Co., Ltd.
510(k) number: K251389
Product code: EFB
Decision: Substantially Equivalent (SESE)
Decision date: 2026-01-12
Date received: 2025-05-05
Regulation: 872.4200
Classification name: Handpiece, Air-Powered, Dental
Medical specialty: Dental
Review panel: Dental
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Salon Chen
Address: Rm. 401, Floor 4, Block C, #7, Gui Dan Rd. Side Section Luo Cun St., Shi Shan Nanhai District Foshan CN 528226 528226

FDA Registration Numbers

2032725
3003114027
3008912871
3003934980
1032227
9614686
3002807636
3009074216
1054713
3008770655
8043629
3004884150
8043296
3012187973
3006847937
8044015
9681479
1718912
9614726
1941138
3000219976
2087470
3014471275
2027754
3022516928
3013576763
9614977
2031508
3010864832
1419489
2024980
3015729
3012477813
3003917473
2246821
3012421607
3006540014
3009391651
2523320
2320721
3006113289
3003637274
3005405362
3017619674
3002105090
3030235916
3002696493
3002808149
3003266594
8032033
3013287728
9611253
3007007357
3010364969
9614446
8044167
1422375
3014683120
2183301
3038718579
2133714
3007958831
8010493
3004096429
3005581016
3030126955
3009768364
1413475
2520265
3004082152
8030987
3012336822
8010468
3021283891
3007279848
3023861999
3029780
2916440
2086043
3019381139
2011171
3009302876
3014953747
3017604
1061053
1648564
3003418325
3011300255
3007031016

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EFB

510(k)	Device	Applicant	Decision date
K251388	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)	Foshan Topmed Dental Co., Ltd.	2026-01-12
K242179	Synea Fusion Handpieces (Intensiv & Profin)	W&H Dentalwerk Bürmoos GmbH	2025-02-28
K240337	Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)	Guangdong Jinme Medical Technology Co., Ltd.	2024-11-13
K241074	High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)	Foshan Soco Precision Instrument Co., Ltd.	2024-11-12
K241880	Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)	Nakanishi, Inc.	2024-09-20
K233122	High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)	Litu Tech , Ltd.	2024-04-30
K233308	Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)	Nakanishi, Inc.	2024-04-25
K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors	Foshan Coxo Medical Instrument Co., Ltd.	2023-09-22
K232243	EVO 700 series high speed handpiece	Ttbio Corp.	2023-08-23
K230888	Titanium Turbine	Nakanishi, Inc.	2023-06-02
K221741	TRAUS Air Dental Handpiece	Saeshin Precision Co., Ltd.	2023-02-22
K202674	Medidenta High Speed Handpieces	Pac-Dent, Inc.	2022-12-12
K212910	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	Shenzhen Carejoy Technology Co., Ltd.	2022-11-17
K221548	Dental Air Polishing Handpiece	Guilin Woodpecker Medical Instrument Co., Ltd.	2022-09-28
K221814	OK Handpiece	Jaintek Co.,Ltd	2022-07-15