COMPONEER— 510(k) K112168

Substantially Equivalent

Coltene/Whaledent AG

FDA 510(k) clearance K112168 for COMPONEER, Substantially Equivalent on 2011-11-21. 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: 2011-07-28
Decision date: 2011-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuyahoga Falls, OH, US

Download summary PDF View on FDA.gov ↗

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