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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K254163
Device Name VarioSurg 4
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Applicant Contact Kikuchi Masaaki
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact Dave Yungvirt
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received12/22/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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