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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K233308
Device Name Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Applicant Contact Masaaki Kikuchi
Correspondent
Globizz Corpration
1411 W. 190th St., Suite #200
Gardena,  CA  90248
Correspondent Contact Takahiro Haruyama
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/29/2023
Decision Date 04/25/2024
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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