Cleared Traditional

Dental High-speed Turbine Handpiece

K170229 · Guangdong Jinme Medical Technology Co., Ltd. · Dental
Nov 2017
Decision
287d
Days
Class 1
Risk

About This 510(k) Submission

K170229 is an FDA 510(k) clearance for the Dental High-speed Turbine Handpiece, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Guangdong Jinme Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on November 8, 2017, 287 days after receiving the submission on January 25, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K170229 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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