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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 K912707
Device Name CLEARFIL LINER BOND SYSTEM
Applicant
KURARAY CO.
200 PARK AVE.
NEW YORK,  NY  10166
Applicant Contact TOHRU SHIMIZU
Correspondent
KURARAY CO.
200 PARK AVE.
NEW YORK,  NY  10166
Correspondent Contact TOHRU SHIMIZU
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/19/1991
Decision Date 08/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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