Cleared Traditional

K243692 - EnDrive (EnDriveUS)

K243692 is an FDA 510(k) clearance for EnDrive (EnDriveUS), manufactured by Advanced Technology Research (A.T.R.) S.R.L.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K243692 · Advanced Technology Research (A.T.R.) S.R.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
266d
Days
Class 1
Risk

K243692 is an FDA 510(k) clearance for the EnDrive (EnDriveUS). Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Advanced Technology Research (A.T.R.) S.R.L. (Pistoia, IT). The FDA issued a Cleared decision on August 22, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Technology Research (A.T.R.) S.R.L. devices

FDA 510(k) Submission Details - K243692

510(k) Number K243692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 45
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K243692.
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