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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 K230106
Device Name General Cutting Straight
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Applicant Contact Masaaki Kikuchi
Correspondent
Ken Block Consulting, LLC
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Dr. Akiko Dohi
Regulation Number872.4200
Classification Product Code
EGS  
Date Received01/13/2023
Decision Date 05/24/2023
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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