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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 K860708
Device Name PHOTO CLEARFIL OPAQUER
Applicant
Kuraray Co.
875 Ave. Of The Americas
New York,  NY  10001
Applicant Contact PAUL ROBERTS
Correspondent
Kuraray Co.
875 Ave. Of The Americas
New York,  NY  10001
Correspondent Contact PAUL ROBERTS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/26/1986
Decision Date 04/17/1986
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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