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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 K131432
Device Name CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL
Applicant
KURARAY NORITAKE DENTAL INC.
OTE CENTER BLDG 7F
1-1-3, OTEMACHI
CHIYODA-KU,  JP 100-0004
Applicant Contact MICHIO TAKIGAWA
Correspondent
KURARAY NORITAKE DENTAL INC.
OTE CENTER BLDG 7F
1-1-3, OTEMACHI
CHIYODA-KU,  JP 100-0004
Correspondent Contact MICHIO TAKIGAWA
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Codes
EBF   EMA  
Date Received05/17/2013
Decision Date 08/22/2013
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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