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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K242432
Device Name MT-Bone
Applicant
Mectron S.p.A.
Via Loreto 15/A
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 Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received08/16/2024
Decision Date 08/19/2024
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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