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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K243692
Device Name EnDrive (EnDriveUS)
Applicant
Advanced Technology Research (A.T.R.) S.R.L.
Via San Donato 345
Pistoia,  IT 51100
Applicant Contact Lorenzo Baroncelli
Correspondent
Advanced Technology Research (A.T.R.) S.R.L.
Via San Donato 345
Pistoia,  IT 51100
Correspondent Contact Lorenzo Baroncelli
Regulation Number872.4200
Classification Product Code
EKX  
Subsequent Product Code
LQY  
Date Received11/29/2024
Decision Date 08/22/2025
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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