Cleared Traditional

Endo Motor

K220829 · Foshan Coxo Medical Instrument Co., Ltd. · Dental
May 2023
Decision
422d
Days
Class 1
Risk

About This 510(k) Submission

K220829 is an FDA 510(k) clearance for the Endo Motor, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Foshan Coxo Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 18, 2023, 422 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 K220829 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2022
Decision Date May 18, 2023
Days to Decision 422 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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