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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 K141659
Device Name PRISM ZIRCONIA, ST-98
Applicant
A & D Dental Innovations
9308 Evening Primrose Path
Austin,  TX  78750
Applicant Contact YOONHO JUN
Correspondent
A & D Dental Innovations
9308 Evening Primrose Path
Austin,  TX  78750
Correspondent Contact YOONHO JUN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/20/2014
Decision Date 10/09/2014
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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