FDA · official record K112967Substantially Equivalent

PMMA CAD/CAM DISC

Name: PMMA CAD/CAM DISC — FDA K112967
Creator: Polident D.O.O., Dental Products Industry
Keywords: PMMA CAD/CAM DISC, PMMA CAD/CAM DISC, K112967, EBG, FDA

United StatesEBGPolident D.O.O., Dental Products Industry

Verified

Official record identity

FDA application number: K112967
Decision date: August 28, 2012
Published decision: Substantially Equivalent

Classification

Product code: EBG

Published parties

Applicant: Polident D.O.O., Dental Products Industry

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2011-10-05
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3770

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.