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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 K033938
Device Name CLEARFIL PROTECT BOND
Applicant
Kuraray Medical, Inc.
1425 K St., NW
11th Floor
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
Kuraray Medical, Inc.
1425 K St., NW
11th Floor
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
LBH  
Date Received12/19/2003
Decision Date 01/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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