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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 K143090
Device Name LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
Applicant
Talladium, Inc.
27360 W. Muirfield Ln.
Valencia,  CA  91355
Applicant Contact ELINA FASKHUTDINOVA
Correspondent
Talladium, Inc.
27360 W. Muirfield Ln.
Valencia,  CA  91355
Correspondent Contact ELINA FASKHUTDINOVA
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/28/2014
Decision Date 06/15/2015
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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