Cleared Traditional

K170236 - Dental Low-speed Turbine Handpiece

K170236 is an FDA 510(k) clearance for Dental Low-speed Turbine Handpiece, manufactured by Guangdong Jinme Medical Technology Co., Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K170236 · Guangdong Jinme Medical Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K170236

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 128d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

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 Consultant

Guangzhou GLOMED Biological Technology Co., Ltd.
Cecilia Ceng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 205
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K170236.
Concentrix MX-AC High-Speed Handpiece
K173465 · Dentalez, Inc. · Mar 2018
PERIO-FLOW nozzle
K171174 · E.M.S Electro Medical Systems S.A · Dec 2017
W&H Assistina Twin
K171553 · W&H Dentalwerk Buermoos GmbH · Dec 2017
Dental High-speed Turbine Handpiece
K170229 · Guangdong Jinme Medical Technology Co., Ltd. · Nov 2017
Premium Plus Prophy Air Motor
K170261 · Premium Plus International Limited · Oct 2017
PANA SPRAY Plus
K163483 · Nakanishi, Inc. · Aug 2017