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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 K871636
Device Name CLEARFIL PORCELAIN BOND
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 Number872.3200
Classification Product Code
KLE  
Date Received04/27/1987
Decision Date 07/02/1987
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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