One Coat 7 Universal— 510(k) K152243

Substantially Equivalent

Coltene/Whaledent AG

FDA 510(k) clearance K152243 for One Coat 7 Universal, Substantially Equivalent on 2015-12-09. Applicant: Coltene/Whaledent AG. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent AG
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2015-08-10
Decision date: 2015-12-09
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.