APROXI 1100 AND 4000 SERIES DENTAL INLAYS— 510(k) K073047

Name: FDA 510(k) clearance K073047
Creator: U.S. Food and Drug Administration
Published: 2008-08-07

Substantially Equivalent

Aproxi Aps

FDA 510(k) clearance K073047 for APROXI 1100 AND 4000 SERIES DENTAL INLAYS, Substantially Equivalent on 2008-08-07. Applicant: Aproxi Aps. Device class: 2.

Clearance details

Applicant: Aproxi Aps
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2007-10-29
Decision date: 2008-08-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Vaerlose, DK

Download summary PDF View on FDA.gov ↗

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