DuoCem— 510(k) K160800

Substantially Equivalent

Coltene/Whaledent AG

FDA 510(k) clearance K160800 for DuoCem, Substantially Equivalent on 2016-11-16. Applicant: Coltene/Whaledent AG. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent AG
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2016-03-23
Decision date: 2016-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altstatten, 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.