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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 K925383
Device Name PHOTO CLEARFIL OPAQUER
Applicant
Kuraray Co.
200 Park Ave.
New York,  NY  10166
Applicant Contact KYOICHIRO SHIBATANI
Correspondent
Kuraray Co.
200 Park Ave.
New York,  NY  10166
Correspondent Contact KYOICHIRO SHIBATANI
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/23/1992
Decision Date 01/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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