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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 K260773
Device Name Varios Combi Pro2
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Applicant Contact Kikuchi Masaaki
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.4850
Classification Product Code
ELC  
Subsequent Product Code
KOJ  
Date Received03/09/2026
Decision Date 03/10/2026
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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