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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K170275
Device Name Tri Auto ZX2
Applicant
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Applicant Contact KEISUKE MORI
Correspondent
Fish & Richardson, P.C.
901 15th, St. N.W
Suite 700
Washington Dc,  DC  20005
Correspondent Contact KEITH A. BARRITT
Regulation Number872.4200
Classification Product Code
EKX  
Subsequent Product Code
LQY  
Date Received01/30/2017
Decision Date 09/11/2017
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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