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510(k) K243692

EnDrive (EnDriveUS) by Advanced Technology Research (A.T.R.) S.R.L. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2025
Date Received
November 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Advanced Technology Research (A.T.R.) S.R.L.

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