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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K010196
Device Name TOTAL CURE
Applicant
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Applicant Contact CYNDY ORIS
Correspondent
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Correspondent Contact CYNDY ORIS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/22/2001
Decision Date 04/05/2001
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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