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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
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