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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 K143140
Device Name G-Premio BOND
Applicant
GC AMERICA, INC.
3737 WEST 127TH ST.
ALSIP,  IL  60803
Applicant Contact Dr. Mark Heiss
Correspondent
GC AMERICA, INC.
3737 WEST 127TH ST.
ALSIP,  IL  60803
Correspondent Contact Dr. Mark Heiss
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/03/2014
Decision Date 04/20/2015
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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