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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 K974486
Device Name CLEARFIL LINER BOND 2V
Applicant
KURARAY AMERICA, INC.
200 PARK AVE.
NEW YORK,  NY  10166 -3098
Applicant Contact KOJI FUJITA
Correspondent
KURARAY AMERICA, INC.
200 PARK AVE.
NEW YORK,  NY  10166 -3098
Correspondent Contact KOJI FUJITA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/26/1997
Decision Date 01/29/1998
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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