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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K251689
Device Name VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Applicant Contact Kikuchi Masaaki
Correspondent
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Correspondent Contact Saito Kaori
Regulation Number872.4850
Classification Product Code
ELC  
Date Received06/02/2025
Decision Date 09/19/2025
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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