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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K161025
Device Name priti multidisc ZrO2 High Translucent
Applicant
PRITIDENTA GMBH
MEISENWEG 37
LEINFELDEN-ECHTERDINGEN,  DE 70771
Applicant Contact MAGDALENA GEIGENBERGER
Correspondent
KARA & ASSOCIATES
1170 HOWELL MILL ROAD
SUITE 300
ATLANTA,  GA  30318
Correspondent Contact MAGDALENA GEIGENBERGER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/12/2016
Decision Date 02/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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