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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 K992248
Device Name POST CEMENT HI-X
Applicant
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Applicant Contact KATHRYN B PATTERSON
Correspondent
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Correspondent Contact KATHRYN B PATTERSON
Regulation Number872.3690
Classification Product Code
EBF  
Date Received07/06/1999
Decision Date 08/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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