EnDrive (EnDriveUS)— 510(k) K243692

Name: FDA 510(k) clearance K243692
Creator: U.S. Food and Drug Administration
Published: 2025-08-22

Substantially Equivalent

Advanced Technology Research (A.T.R.) S.R.L.

FDA 510(k) clearance K243692 for EnDrive (EnDriveUS), Substantially Equivalent on 2025-08-22. Applicant: Advanced Technology Research (A.T.R.) S.R.L.. Device class: 1.

Clearance details

Applicant: Advanced Technology Research (A.T.R.) S.R.L.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2024-11-29
Decision date: 2025-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pistoia, IT

Download summary PDF View on FDA.gov ↗

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