NOBELRONDO DENTAL CERAMIC - ZIRCONIA— 510(k) K043312

Name: FDA 510(k) clearance K043312
Creator: U.S. Food and Drug Administration
Published: 2005-02-01

Substantially Equivalent

Nobel Biocare USA, LLC

FDA 510(k) clearance K043312 for NOBELRONDO DENTAL CERAMIC - ZIRCONIA, Substantially Equivalent on 2005-02-01. Applicant: Nobel Biocare USA, LLC. Device class: 2.

Clearance details

Applicant: Nobel Biocare USA, LLC
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2004-12-01
Decision date: 2005-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda,, CA, US

Download summary PDF View on FDA.gov ↗

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