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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
Models 1210-KA, 1216-KA, 1217-KA
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,  JA 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 (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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