EthanZir Zirconia— 510(k) K191304

Name: FDA 510(k) clearance K191304
Creator: U.S. Food and Drug Administration
Published: 2019-11-04

Substantially Equivalent

Besorah Dental Solutions NZ Limited

FDA 510(k) clearance K191304 for EthanZir Zirconia, Substantially Equivalent on 2019-11-04. Applicant: Besorah Dental Solutions NZ Limited. Device class: 2.

Clearance details

Applicant: Besorah Dental Solutions NZ Limited
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2019-05-14
Decision date: 2019-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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