StarCeram® Z-Nature, StarCeram® Z-Smile— 510(k) K143656

Name: FDA 510(k) clearance K143656
Creator: U.S. Food and Drug Administration
Published: 2015-07-09

Substantially Equivalent

H.C. Starck Ceramics GmbH

FDA 510(k) clearance K143656 for StarCeram® Z-Nature, StarCeram® Z-Smile, Substantially Equivalent on 2015-07-09. Applicant: H.C. Starck Ceramics GmbH. Device class: 2.

Clearance details

Applicant: H.C. Starck Ceramics GmbH
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2014-12-23
Decision date: 2015-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Selb, DE

Download summary PDF View on FDA.gov ↗

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