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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
Predetermined Change
Control Plan Authorized		 No
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