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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 K853002
Device Name BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)
Applicant
Bisco, Inc.
765 Springer Dr.
Lombard,  IL  60148
Applicant Contact BYOUNG I SUN
Correspondent
Bisco, Inc.
765 Springer Dr.
Lombard,  IL  60148
Correspondent Contact BYOUNG I SUN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received07/16/1985
Decision Date 08/16/1985
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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