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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 K931857
Device Name SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT
Applicant
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Applicant Contact SHARON A LUTTON
Correspondent
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Correspondent Contact SHARON A LUTTON
Regulation Number872.3765
Classification Product Code
EBC  
Date Received04/13/1993
Decision Date 07/22/1993
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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