PMMA CAD/CAM DISC— 510(k) K112967

Name: FDA 510(k) clearance K112967
Creator: U.S. Food and Drug Administration
Published: 2012-08-28

Substantially Equivalent

Polident D.O.O., Dental Products Industry

FDA 510(k) clearance K112967 for PMMA CAD/CAM DISC, Substantially Equivalent on 2012-08-28. Applicant: Polident D.O.O., Dental Products Industry. Device class: 2.

Clearance details

Applicant: Polident D.O.O., Dental Products Industry
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2011-10-05
Decision date: 2012-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Volcja Draga, SI

Download summary PDF View on FDA.gov ↗

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