BRILLIANT Crios— 510(k) K181500

Substantially Equivalent

Coltene/Whaledent AG

FDA 510(k) clearance K181500 for BRILLIANT Crios, Substantially Equivalent on 2018-08-15. Applicant: Coltene/Whaledent AG. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2018-06-07
Decision date: 2018-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altstätten Sg, 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.