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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K091705
Device Name PRIMER PLUS
Applicant
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Applicant Contact Michelle Schiltz-Taing
Correspondent
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Correspondent Contact Michelle Schiltz-Taing
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/10/2009
Decision Date 08/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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