EnDrive

Basic Information

• Brand Name: EnDrive
• Primary DI: 08056814270117
• Version / Model: EnDriveUS
• Company Name: ADVANCED TECHNOLOGY RESEARCH A.T.R. SRL
• Labeler DUNS: 630782852
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-26
• Public Version: 1
• Public Version Date: 2025-12-04
• Public Version Status: New
• Public Device Record Key: b08d5b41-3d66-4d1f-b7bf-d755baec9d9a

Device Description

EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating endodontic instruments with torque control, or retreatment of an already treated tooth, with integrated apex locator. We can identify two different functional principles: one is the motor function which serves to shape the root canal, the other is the apex locator function to determine the apex approach when the file is in the root canal. The motor function, when the file has a movement transmitted from the motor through the contra-angle, allows the proper shaping of a root canal with infected pulp through rotary or reciprocating movement, helping to remove debris and infected tissue from the canal. The motor, controlled in speed and torque, uses brushless DC technology with 3 phases and 3 Hall sensors, driven by an embedded software. The apex locator function allows to determine when, during an endodontic treatment, the tip of an endodontic instrument, in steel or nickel-titanium, inserted by the dentist inside the root canal, is at the apex of the canal. Two electrodes are applied to the patient, a lip clip on the lip and a file clamp to the endodontic instrument positioned inside the canal (see figure below – same signal can be transmitted as well through the motor to the tip during the canal shaping). When the device signals the apex has been reached, the dentist positions the instrument stopper on the dental crown and indirectly goes to measure the working length of the canal using a ruler for endodontic instruments, so the length from which he must remove the infected pulp.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1
LQY	Locator, Root Apex	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
66245	Dental surgical power tool motorized handpiece/set, electric	An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056814270117	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243692	000