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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Rotary Bone Cutting
510(k) Number K211584
Device Name Oral Surgery Contra
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 Yulia Nikova
Regulation Number872.4120
Classification Product Code
KMW  
Date Received05/24/2021
Decision Date 08/19/2021
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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