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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 K943165
Device Name CLEARFIL PHOTO BOND
Applicant
KURARAY COMPANY, LTD.
200 PARK AVE.
NEW YORK,  NY  10166 -3098
Applicant Contact KYOICHIRO SHIBATANI
Correspondent
KURARAY COMPANY, LTD.
200 PARK AVE.
NEW YORK,  NY  10166 -3098
Correspondent Contact KYOICHIRO SHIBATANI
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/01/1994
Decision Date 08/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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