CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA— 510(k) K113431

Name: FDA 510(k) clearance K113431
Creator: U.S. Food and Drug Administration
Published: 2012-03-30

Substantially Equivalent

Bettini S.P.A.

FDA 510(k) clearance K113431 for CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA, Substantially Equivalent on 2012-03-30. Applicant: Bettini S.P.A.. Device class: 2.

Clearance details

Applicant: Bettini S.P.A.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2011-11-21
Decision date: 2012-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ormond Beach, FL, 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.