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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 K100232
Device Name LUMINESSE ZR BLANKS
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 Received01/26/2010
Decision Date 05/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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