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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 K241880
Device Name Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Applicant Contact Kikuchi Masaaki
Correspondent
Nakanishi, Inc.
Tix Tower Ueno 9f
4-8-1, Higashiueno
Taito-Ku,  JP 110-0015
Correspondent Contact Ikeda Satoru
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/28/2024
Decision Date 09/20/2024
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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