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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 K152023
Device Name Luminesse Shaded Zirconia SZ
Applicant
Talladium, Inc.
27360 W. Muirfield Ln.
Valencia,  CA  91355
Applicant Contact Edward Harms
Correspondent
Talladium, Inc.
27360 W. Muirfield Ln.
Valencia,  CA  91355
Correspondent Contact EDWARD HARMS
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/21/2015
Decision Date 09/15/2016
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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