Cleared Traditional

Dental Handpiece, Model CA160, CA160L, and CA500L

K220577 · Micro-Nx Co., Ltd. · Dental
Jul 2022
Decision
151d
Days
Class 1
Risk

About This 510(k) Submission

K220577 is an FDA 510(k) clearance for the Dental Handpiece, Model CA160, CA160L, and CA500L, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Micro-Nx Co., Ltd. (Dong-Gu, KR). The FDA issued a Cleared decision on July 29, 2022, 151 days after receiving the submission on February 28, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K220577 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2022
Decision Date July 29, 2022
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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