CERAMICS2IN1— 510(k) K100150

Substantially Equivalent

Biodenta Swiss AG

FDA 510(k) clearance K100150 for CERAMICS2IN1, Substantially Equivalent on 2010-05-25. Applicant: Biodenta Swiss AG. Device class: 2.

Clearance details

Applicant: Biodenta Swiss AG
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2010-01-19
Decision date: 2010-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berneck, St.Gallen, 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.