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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K251425
Device Name turbodent touch
Applicant
Mectron S.p.A
Via Loreto 15
Carasco,  IT 16042
Applicant Contact Chiara Acunzo
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.6080
Classification Product Code
KOJ  
Subsequent Product Code
ELC  
Date Received05/08/2025
Decision Date 05/09/2025
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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