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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
Original Applicant
KURARAY NORITAKE DENTAL INC.
ote center bldg 7f
1-1-3, otemachi
chiyoda-ku,  JP 100-0004
Original 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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