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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 K123653
Device Name SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
Applicant
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Applicant Contact Michelle Schiltz-Taing
Correspondent
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Correspondent Contact Michelle Schiltz-Taing
Regulation Number872.3260
Classification Product Code
LBH  
Date Received11/27/2012
Decision Date 06/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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