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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K112967
Device Name PMMA CAD/CAM DISC
Applicant
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
VOLCJA DRAGA 42
VOLCJA DRAGA,  SI 5293
Applicant Contact JANJA LIPUSCEK
Correspondent
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
VOLCJA DRAGA 42
VOLCJA DRAGA,  SI 5293
Correspondent Contact JANJA LIPUSCEK
Regulation Number872.3770
Classification Product Code
EBG  
Date Received10/05/2011
Decision Date 08/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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