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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 K895731
Device Name DEN-MAT CERINATE PORCELAIN
Applicant
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Applicant Contact W. R GLACE
Correspondent
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Correspondent Contact W. R GLACE
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/26/1989
Decision Date 08/03/1990
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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