Cleared Traditional

Dental Implantation Systems, Dental Electrical Motors

K220831 · Foshan Coxo Medical Instrument Co., Ltd. · Dental
Sep 2022
Decision
189d
Days
Class 1
Risk

About This 510(k) Submission

K220831 is an FDA 510(k) clearance for the Dental Implantation Systems, Dental Electrical Motors, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Foshan Coxo Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on September 27, 2022, 189 days after receiving the submission on March 22, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K220831 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2022
Decision Date September 27, 2022
Days to Decision 189 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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