Cleared Traditional

Dental Electric Motor

K203706 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental
Jan 2022
Decision
391d
Days
Class 1
Risk

About This 510(k) Submission

K203706 is an FDA 510(k) clearance for the Dental Electric Motor, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on January 13, 2022, 391 days after receiving the submission on December 18, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K203706 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2020
Decision Date January 13, 2022
Days to Decision 391 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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