Cleared Traditional

Dental Handpiece

K192809 · Micro-Nx Co., Ltd. · Dental
Aug 2020
Decision
329d
Days
Class 1
Risk

About This 510(k) Submission

K192809 is an FDA 510(k) clearance for the Dental Handpiece, a Handpiece, Belt And/or Gear Driven, Dental (Class I — General Controls, product code EFA), submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on August 25, 2020, 329 days after receiving the submission on October 1, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K192809 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2019
Decision Date August 25, 2020
Days to Decision 329 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFA — Handpiece, Belt And/or Gear Driven, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200