PRESIDENT The Original— 510(k) K220097

Substantially Equivalent

Coltène/Whaledent AG

FDA 510(k) clearance K220097 for PRESIDENT The Original, Substantially Equivalent on 2022-01-13. Applicant: Coltène/Whaledent AG. Device class: 2.

Clearance details

Applicant: Coltène/Whaledent AG
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2022-01-12
Decision date: 2022-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altstätten, CH

Download summary PDF View on FDA.gov ↗

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