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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 K021427
Device Name CLEARFIL SA PRIMER
Applicant
KURARAY MEDICAL INC.
101 EAST 52ND STREET, 26TH FL.
NEW YORK,  NY  10022
Applicant Contact MASAYA SASAKI
Correspondent
KURARAY MEDICAL INC.
101 EAST 52ND STREET, 26TH FL.
NEW YORK,  NY  10022
Correspondent Contact MASAYA SASAKI
Regulation Number872.3200
Classification Product Code
KLE  
Date Received05/03/2002
Decision Date 06/07/2002
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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