NACERA Z AND NACERA Z MEDIUM— 510(k) K080195

Name: FDA 510(k) clearance K080195
Creator: U.S. Food and Drug Administration
Published: 2008-04-28

Substantially Equivalent

Doceram Medical Ceramics GmbH

FDA 510(k) clearance K080195 for NACERA Z AND NACERA Z MEDIUM, Substantially Equivalent on 2008-04-28. Applicant: Doceram Medical Ceramics GmbH. Device class: 2.

Clearance details

Applicant: Doceram Medical Ceramics GmbH
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2008-01-25
Decision date: 2008-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dortmund, Nrw, DE

Download summary PDF View on FDA.gov ↗

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