Dental Low-speed Turbine Handpiece

Q: What is the product code of K170236?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.

FDA 510(k) K170236 · Guangdong Jinme Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK170236

Submission

Device name: Dental Low-speed Turbine Handpiece
Applicant: Guangdong Jinme Medical Technology Co., Ltd.
Foshan, CN
Received: January 25, 2017
Decision date: November 21, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EFB – Handpiece, Air-Powered, Dental
Device class: Class I (low risk)
Regulation: 21 CFR 872.4200
Specialty: Dental

Other 510(k)s with product code EFB

510(k)	Device	Applicant	Decision
K251389	High speed air turbine handpieceEFB · Traditional	Foshan Topmed Dental Co., Ltd.	01/12/2026SE
K251388	Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional	Foshan Topmed Dental Co., Ltd.	01/12/2026SE
K242179	Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional	W&H Dentalwerk Bürmoos GmbH	02/28/2025SE
K240337	Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional	Guangdong Jinme Medical Technology Co., Ltd.	11/13/2024SE
K241074	High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional	Foshan Soco Precision Instrument Co., Ltd.	11/12/2024SE
K241880	Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional	Nakanishi, Inc.	09/20/2024SE
K233122	High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional	Litu Tech , Ltd.	04/30/2024SE
K233308	Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional	Nakanishi, Inc.	04/25/2024SE
K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional	Foshan Coxo Medical Instrument Co., Ltd.	09/22/2023SE
K232243	EVO 700 series high speed handpieceEFB · Special	Ttbio Corp.	08/23/2023SE

More from Ttbio Corp.

510(k)	Device	Decision
K240337	Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional	11/13/2024SE
K240340	Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional	07/18/2024SE
K170229	Dental High-speed Turbine HandpieceEFB · Traditional	11/08/2017SE

Questions and answers

When was Dental Low-speed Turbine Handpiece cleared by the FDA?

Dental Low-speed Turbine Handpiece (K170236) received a 510(k) decision of Substantially Equivalent on November 21, 2017, 300 days after the submission was received.

What is the product code of K170236?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.