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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
Applicant
NAKANISHI, INC.
4-4-17 HONGO
BUNKYO-KU,  JP 113-0033
Applicant Contact FUMIAKI KANAI
Correspondent
NAKANISHI, INC.
4-4-17 HONGO
BUNKYO-KU,  JP 113-0033
Correspondent Contact FUMIAKI KANAI
Regulation Number872.4200
Classification Product Code
EGS  
Date Received06/29/2012
Decision Date 02/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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