Cleared Traditional

Dental Low-speed Turbine Handpiece

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

About This 510(k) Submission

K170236 is an FDA 510(k) clearance for the Dental Low-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 21, 2017, 300 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 K170236 FDA.gov
FDA Decision Cleared 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

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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