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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 K851030
Device Name TEMREX-DENTIN VARNISH
Applicant
TEMREX CORP.
SCIENTIFIC PHARMACEUTICALS, IN
1828 EVERGREEN STREET
DUARTE,  CA  91010
Applicant Contact JAN ORLOWSKI
Correspondent
TEMREX CORP.
SCIENTIFIC PHARMACEUTICALS, IN
1828 EVERGREEN STREET
DUARTE,  CA  91010
Correspondent Contact JAN ORLOWSKI
Regulation Number872.3260
Classification Product Code
LBH  
Date Received03/12/1985
Decision Date 06/20/1985
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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