PROXEO Twist Cordless Polishing System PL-40 H— 510(k) K201703

Name: FDA 510(k) clearance K201703
Creator: U.S. Food and Drug Administration
Published: 2021-02-24

Substantially Equivalent

W&H Dentalwerk Buermoos GmbH

FDA 510(k) clearance K201703 for PROXEO Twist Cordless Polishing System PL-40 H, Substantially Equivalent on 2021-02-24. Applicant: W&H Dentalwerk Buermoos GmbH. Device class: 1.

Clearance details

Applicant: W&H Dentalwerk Buermoos GmbH
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2020-06-22
Decision date: 2021-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.