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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K852755
Device Name UNIVAR UNIVERSAL DENTIN VARNISH
Applicant
SCIENTIFIC PHARMACEUTICALS, INC.
1828 EVERGREEN ST.
DUARTE,  CA  91010
Applicant Contact JAN ORLOWSKI
Correspondent
SCIENTIFIC PHARMACEUTICALS, INC.
1828 EVERGREEN ST.
DUARTE,  CA  91010
Correspondent Contact JAN ORLOWSKI
Regulation Number872.3260
Classification Product Code
LBH  
Date Received06/28/1985
Decision Date 09/23/1985
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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