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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 K231391
Device Name Combi Touch
Applicant
Mectron S.p.A.
Via Loreto 15/A
Carasco,  IT 16042
Applicant Contact Edoardo Tronchet
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.4850
Classification Product Code
ELC  
Subsequent Product Code
KOJ  
Date Received05/12/2023
Decision Date 05/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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