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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 K042913
Device Name CLEARFIL TRI-S BOND
Applicant
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Applicant Contact SATOSHI YAMAGUCHI
Correspondent
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Correspondent Contact SATOSHI YAMAGUCHI
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/21/2004
Decision Date 11/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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