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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K854882
Device Name PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
Applicant
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Applicant Contact DIAN TIEGLER
Correspondent
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Correspondent Contact DIAN TIEGLER
Regulation Number872.3765
Classification Product Code
EBC  
Date Received12/06/1985
Decision Date 01/30/1986
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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