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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 K003317
Device Name RENEW LS-1
Applicant
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Applicant Contact CINDY ORIS
Correspondent
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Correspondent Contact CINDY ORIS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/24/2000
Decision Date 11/21/2000
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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