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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 K012734
Device Name CLEARFIL NEW BOND
Applicant
KURARAY MEDICAL INC.
30TH FL. METLIFE BUILDING
200 PARK AVENUE
NEW YORK,  NY  10166
Applicant Contact MASAYA SASAKI
Correspondent
KURARAY MEDICAL INC.
30TH FL. METLIFE BUILDING
200 PARK AVENUE
NEW YORK,  NY  10166
Correspondent Contact MASAYA SASAKI
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/14/2001
Decision Date 09/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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