BISQUE ZIRCONIA BLANKS, TYPE BYZ— 510(k) K081850

Name: FDA 510(k) clearance K081850
Creator: U.S. Food and Drug Administration
Published: 2008-09-25

Substantially Equivalent

Zircar Zirconia, Inc.

FDA 510(k) clearance K081850 for BISQUE ZIRCONIA BLANKS, TYPE BYZ, Substantially Equivalent on 2008-09-25. Applicant: Zircar Zirconia, Inc.. Device class: 2.

Clearance details

Applicant: Zircar Zirconia, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2008-06-30
Decision date: 2008-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.