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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K122421
Device Name TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
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 Number872.3250
Classification Product Code
EJK  
Date Received08/09/2012
Decision Date 12/11/2012
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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