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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
Predetermined Change
Control Plan Authorized		 No
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