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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 K202960
Device Name General Cutting Contra Handpiece
Applicant
Nakanishi, Inc.
700 Shimohnata
Kanuma,  JP 322-8666
Applicant Contact Masaaki Kikuchi
Correspondent
Ken Block Consulting, LLC
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Yulia Nikova
Regulation Number872.4200
Classification Product Code
EGS  
Date Received09/30/2020
Decision Date 10/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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