Y-TZP POWDER AND PROCERA ALLZIRKON— 510(k) K010630

Name: FDA 510(k) clearance K010630
Creator: U.S. Food and Drug Administration
Published: 2001-04-17

Substantially Equivalent

Procera Sandvik, Inc.

FDA 510(k) clearance K010630 for Y-TZP POWDER AND PROCERA ALLZIRKON, Substantially Equivalent on 2001-04-17. Applicant: Procera Sandvik, Inc.. Device class: 2.

Clearance details

Applicant: Procera Sandvik, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2001-03-02
Decision date: 2001-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fair Lawn, NJ, US

Download summary PDF View on FDA.gov ↗

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