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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K864346
Device Name REMBRANDT PORCELAIN TINTING KIT
Applicant
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Applicant Contact ROBERT IBSEN
Correspondent
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Correspondent Contact ROBERT IBSEN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/04/1986
Decision Date 01/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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