Cleared Traditional

K170229 - Dental High-speed Turbine Handpiece

K170229 is an FDA 510(k) clearance for Dental High-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 287-day FDA review.

K170229 · Guangdong Jinme Medical Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Nov 2017
Decision
287d
Days
Class 1
Risk

K170229 is an FDA 510(k) clearance for the Dental High-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 8, 2017 after a review of 287 days - an extended review cycle.

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 - K170229

510(k) Number K170229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date November 08, 2017
Days to Decision 287 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
160d slower than avg
Panel avg: 127d · This submission: 287d
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 Peers - EFB Handpiece, Air-powered, Dental

All 91
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K170229.
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K151912 · E.M.S Electro Medical Systems S.A · Feb 2016
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K131319 · Sirona Dental Systems GmbH · May 2014