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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K023002
Device Name CLEARFIL AP-X PLT
Applicant
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Applicant Contact MASAYA SASAKI
Correspondent
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Correspondent Contact MASAYA SASAKI
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/09/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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