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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 K041471
Device Name G-BOND
Applicant
GC AMERICA INC.
3737 WEST 127TH STREET
ALSIP,  IL  60803
Applicant Contact TERRY L JORITZ
Correspondent
GC AMERICA INC.
3737 WEST 127TH STREET
ALSIP,  IL  60803
Correspondent Contact TERRY L JORITZ
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/02/2004
Decision Date 06/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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