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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, dental
510(k) Number K060701
Device Name BISCEM TRANSLUCENT, BISCEM OPAQUE
Applicant
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Applicant Contact BENJAMIN LICHTENWALNER
Correspondent
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Correspondent Contact BENJAMIN LICHTENWALNER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/16/2006
Decision Date 05/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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