Cleared Traditional

EnDrive (EnDriveUS)

K243692 · Advanced Technology Research (A.T.R.) S.R.L. · Dental

Aug 2025

Decision

266d

Days

Class 1

Risk

About This 510(k) Submission

K243692 is an FDA 510(k) clearance for the EnDrive (EnDriveUS), a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Advanced Technology Research (A.T.R.) S.R.L. (Pistoia, IT). The FDA issued a Cleared decision on August 22, 2025, 266 days after receiving the submission on November 29, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K243692 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2024
Decision Date	August 22, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF