EnDrive

GUDID 08056814270117

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.

ADVANCED TECHNOLOGY RESEARCH A.T.R. SRL

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 08056814270117
• NIH Device Record Key: b08d5b41-3d66-4d1f-b7bf-d755baec9d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnDrive
• Version Model Number: EnDriveUS
• Company DUNS: 630782852
• Company Name: ADVANCED TECHNOLOGY RESEARCH A.T.R. SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com
• Phone: +390573535801
• Email: info@atrdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056814270117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243692

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

[08056814270117]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-04
• Device Publish Date: 2025-11-26