AVANTE Z ZIRCONIA (AS)3 BLOCKS— 510(k) K081749

Name: FDA 510(k) clearance K081749
Creator: U.S. Food and Drug Administration
Published: 2008-09-30

Substantially Equivalent

Pentron Ceramics, Inc.

FDA 510(k) clearance K081749 for AVANTE Z ZIRCONIA (AS)3 BLOCKS, Substantially Equivalent on 2008-09-30. Applicant: Pentron Ceramics, Inc.. Device class: 2.

Clearance details

Applicant: Pentron Ceramics, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2008-06-19
Decision date: 2008-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

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