Cleared Traditional

K170236 - Dental Low-speed Turbine Handpiece (FDA 510(k) Clearance)

Class I Dental device.

K170236 · Guangdong Jinme Medical Technology Co., Ltd. · Dental device
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Nov 2017
Decision
300d
Days
Class 1
Risk

K170236 is an FDA 510(k) clearance for the Dental Low-speed Turbine Handpiece. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Guangdong Jinme Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on November 21, 2017 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Guangdong Jinme Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K170236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date November 21, 2017
Days to Decision 300 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 127d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 260
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K170236.
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)
K251388 · Foshan Topmed Dental Co., Ltd. · Jan 2026
High speed air turbine handpiece
K251389 · Foshan Topmed Dental Co., Ltd. · Jan 2026
Synea Fusion Handpieces (Intensiv & Profin)
K242179 · W&H Dentalwerk B?rmoos GmbH · Feb 2025
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
K240337 · Guangdong Jinme Medical Technology Co., Ltd. · Nov 2024
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)
K241074 · Foshan Soco Precision Instrument Co., Ltd. · Nov 2024
Air Powered Tooth Polishing System (Perio-Mate)
K241880 · Nakanishi, Inc. · Sep 2024