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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 K112118
Device Name DREAMBOND
Applicant
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Applicant Contact Michelle Schiltz-Taing
Correspondent
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Correspondent Contact Michelle Schiltz-Taing
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/25/2011
Decision Date 11/17/2011
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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