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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name handpiece, contra- and right-angle attachment, dental
510(k) Number K121901
Device Name TI-MAX Z45
Original Applicant
4-4-17 hongo
bunkyo-ku,  JA 113-0033
Original Contact fumiaki kanai
Regulation Number872.4200
Classification Product Code
Date Received06/29/2012
Decision Date 02/28/2013
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