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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, And Accessories, Dental
510(k) Number K213477
Device Name Root ZX3
Applicant
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Applicant Contact Fujio Zushi
Correspondent
Fish & Richardson, P.C.
1000 Maine Ave. SW 9th Floor, Suite 1000
Washington,  DC  20024
Correspondent Contact Keith A. Barritt
Regulation Number872.4920
Classification Product Code
EKZ  
Subsequent Product Code
LQY  
Date Received10/29/2021
Decision Date 08/03/2022
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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