Cleared Traditional

Cordless Prophy System, Model: i-Polish

K211531 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental
Dec 2021
Decision
214d
Days
Class 1
Risk

About This 510(k) Submission

K211531 is an FDA 510(k) clearance for the Cordless Prophy System, Model: i-Polish, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on December 17, 2021, 214 days after receiving the submission on May 17, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K211531 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2021
Decision Date December 17, 2021
Days to Decision 214 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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