Cleared Traditional

Dental Air Polishing Handpiece

K221548 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental
Sep 2022
Decision
124d
Days
Class 1
Risk

About This 510(k) Submission

K221548 is an FDA 510(k) clearance for the Dental Air Polishing Handpiece, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin City, CN). The FDA issued a Cleared decision on September 28, 2022, 124 days after receiving the submission on May 27, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K221548 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2022
Decision Date September 28, 2022
Days to Decision 124 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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