GenesisZr 4Y Zirconia— 510(k) K182642

Name: FDA 510(k) clearance K182642
Creator: U.S. Food and Drug Administration
Published: 2019-01-25

Substantially Equivalent

United Dental Resources Corporation

FDA 510(k) clearance K182642 for GenesisZr 4Y Zirconia, Substantially Equivalent on 2019-01-25. Applicant: United Dental Resources Corporation. Device class: 2.

Clearance details

Applicant: United Dental Resources Corporation
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2018-09-24
Decision date: 2019-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: University Park, IL, US

Download summary PDF View on FDA.gov ↗

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