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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 K111980
Device Name CLEARFIL TRI-S BOND PLUS
Applicant
KURARAY AMERICA, INC.
600 LEXINGTON AVE.
26TH FLOOR
NEW YORK,  NY  10022
Applicant Contact KIYOYUKI ARIKAWA
Correspondent
KURARAY AMERICA, INC.
600 LEXINGTON AVE.
26TH FLOOR
NEW YORK,  NY  10022
Correspondent Contact KIYOYUKI ARIKAWA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/12/2011
Decision Date 10/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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