Cordless Prophy System, Model: i-Polish— 510(k) K211531

Name: FDA 510(k) clearance K211531
Creator: U.S. Food and Drug Administration
Published: 2021-12-17

Substantially Equivalent

Guilin Woodpecker Medical Instrument Co., Ltd.

FDA 510(k) clearance K211531 for Cordless Prophy System, Model: i-Polish, Substantially Equivalent on 2021-12-17. Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.. Device class: 1.

Clearance details

Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2021-05-17
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilin, CN

Download summary PDF View on FDA.gov ↗

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