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 brush less 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. 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 the dentist must remove the infected pulp.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for EnDrive (EnDriveUS) outlines the device's technical specifications and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with a detailed test set, ground truth, expert adjudication, or MRMC study).

The document primarily focuses on demonstrating substantial equivalence through bench testing of key performance characteristics and compliance with various standards.

Here's a breakdown of the information available and what is not disclosed in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7), here's the information that can be extracted:

Feature/Metric	Acceptance Criteria (Implied/Predicate)	Reported Device Performance (EnDrive)
Motor Speed Range	150-1000 rpm (Predicate)	250-1000 rpm
Apex Locator Accuracy	± 0.5mm	± 0.5mm
Torque Range	0.6 - 3.9 N·cm (Predicate)	0.4 - 5.0 N·cm

Note: The "acceptance criteria" for EnDrive are largely implicitly defined by its substantial equivalence to the predicate device (Endo Motor, K220829). The document states that EnDrive's performance is either within or acceptably comparable to the predicate's ranges.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "bench test reports" but does not provide details on the number of samples, root canals, or measurements included in these tests for speed, torque, or apex locator accuracy.
Data Provenance: Not explicitly stated as "country of origin." However, the applicant is "Advanced Technology Research (A.T.R.) s.r.l." located in Pistoia, Italy. The testing described appears to be a non-clinical, bench-top study rather than a human clinical trial, making "retrospective or prospective" less applicable in the typical sense. It implies prospective testing conducted on the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable/Not specified. For the bench tests described (motor speed, torque, apex locator accuracy), the "ground truth" would typically be established by calibrated measurement instruments, not human experts. Human experts are generally relevant for interpreting images, diagnosing conditions, or performing clinical assessments, none of which are described in the performance tests here.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess data, and disagreements need to be resolved. Since the reported performance tests are bench-top measurements against instrument-derived "ground truth," such a method is not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The document does not describe any study involving human readers assessing cases with or without AI assistance. The device is a "motorized handpiece with integrated apex locator," not an AI diagnostic/interpretive tool in the context of MRMC studies.
Effect size of improvement with AI vs without AI assistance: Not applicable, as no MRMC study was conducted or described.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop)

Was a standalone study done? Yes, in essence. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section describes performance characteristics (motor speed, apex locator accuracy, torque) of the device itself, implying standalone performance. The device's "integrated apex locator" function is a component of the device's overall functionality, and its accuracy (±0.5mm) is reported as a standalone metric for that function.
- However, it's crucial to distinguish this from AI/software-only standalone performance. This is about the electromechanical performance of the hardware and its integrated functions, not a purely software-based diagnostic algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For the reported performance metrics (motor speed, torque, apex locator accuracy), the ground truth would be established by calibrated reference instruments or precise physical measurements. For example:
- Motor Speed: A calibrated tachometer or speed sensor.
- Torque: A calibrated torque sensor.
- Apex Locator Accuracy: Physical measurement of root canal length (e.g., using a micrometer or precise ruler) in a controlled phantom/model alongside electronic readings.
- General compliance with standards implies that the tests performed to meet those standards would use appropriately robust and validated ground truth methodologies.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified/Not applicable in the AI/ML sense. The EnDrive is described as an electronic medical device with embedded software controlling motor functions and an apex locator. While "embedded software" runs the device, the document does not suggest the use of machine learning or AI models that would require a distinct "training set" in the context of typical AI/ML submissions to the FDA (e.g., for diagnostic image analysis). The software likely relies on algorithms and control logic rather than learned patterns from a training dataset.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable/Not specified. As there's no mention of a machine learning "training set," there's no information on how its ground truth would be established. The device's functionality is based on established engineering principles for electromechanical control and impedance-based apex localization, not typically on a data-driven training paradigm requiring labeled ground truth in the way a diagnostic AI does.

In summary: The provided FDA clearance letter focuses on establishing substantial equivalence for a medical device (a dental handpiece with an integrated apex locator) primarily through bench testing against performance specifications and compliance with relevant industry standards. It does not detail a clinical study with elements like a human-adjudicated test set, MRMC comparisons, or specific AI/ML training data that your request implies. The performance claims are limited to the mechanical and electronic accuracy of the device's core functions.

Summary

FDA 510(k) Clearance Letter - EnDrive (EnDriveUS)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 22, 2025

Advanced Technology Research (A.T.R.) s.r.l.
Lorenzo Baroncelli
Quality and Regulatory Manager
Via San Donato 345
Pistoia, PT 51100
ITALY

Re: K243692
Trade/Device Name: EnDrive (EnDriveUS)
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece And Accessories
Regulatory Class: Class I, reserved
Product Code: EKX, LQY
Dated: November 29, 2024
Received: November 29, 2024

Dear Lorenzo Baroncelli:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K243692 - Lorenzo Baroncelli Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K243692 - Lorenzo Baroncelli Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K243692

Device Name: EnDrive (EnDriveUS)

Indications for Use (Describe):

Type of Use (Select one or both, as applicable):

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

510(k) #: K243692
Prepared on: 2025-08-20

Contact Details - 21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Advanced Technology Research (A.T.R.) s.r.l.
Applicant Address	Via San Donato 345 Pistoia PT 51100 Italy
Applicant Contact Telephone	+390573535861
Applicant Contact	Mr. Lorenzo Baroncelli
Applicant Contact Email	lorenzo.baroncelli@atrdental.com

Device Name - 21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	EnDrive (EnDriveUS)
Common Name	Dental handpiece and accessories
Classification Name	Handpiece, Direct Drive, Ac-Powered
Regulation Number	872.4200
Product Code(s)	EKX, LQY

Legally Marketed Predicate Devices - 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K220829	Endo Motor	EKX

Device Description Summary - 21 CFR 807.92(a)(4)

Intended Use/Indications for Use - 21 CFR 807.92(a)(5)

Indications for Use Comparison - 21 CFR 807.92(a)(5)

The intended use of the two devices are equivalent, intact:

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EnDrive intended use: 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.

Endo Motor intended use: The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized hand piece and device for measuring canal length.

Technological Comparison - 21 CFR 807.92(a)(6)

The EnDrive motor is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium battery used for the hand piece and NiMH battery for the control unit; the control unit is charged by a medical adapter. LCD displays parameters such as selected NiTi file, speed, torque, apex position, etc. Users can also set and modify the settings using the touch screen.

The handpiece connects automatically to the control unit via Bluetooth.

The EnDrive is an endodontic treatment motorized equipment with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized hand piece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The accessories of EnDrive (contra-angle, file clamp and lip clip) are intended to be sterilized prior to use.

The material composition of root canal files that can be used with the EnDrive is Nickel titanium (NiTi). These files are not included in the submission.

There are three working modes as:

Endo motor mode: root canal preparation.
Apex locator mode: root canal length measurement.
Multi-function mode: undertake root canal measurement and preparation.

The subject device, and the predicate device, C-SMART-I Pilot (K220829), share the same intended use as motorized endodontic hand pieces with integrated apex locator capability. Both are intended for root canal preparation and canal length measurement in dental clinical settings, operated by qualified dental professionals. The anatomical site of use (root canal and softened dentin) and the clinical environment (dental clinics, hospitals, university settings) are identical. The two devices are based on the same fundamental technology, consisting of a cordless motorized hand piece powered by an internal rechargeable battery, coupled with a control unit that provides real-time display of operating parameters such as speed, torque, and apex position. Both devices support continuous rotation and reciprocating movements, as well as multiple operating modes: endo motor, apex locator, and combined multifunction mode. Safety mechanisms are equivalent, including automatic reverse rotation when preset torque thresholds are reached. The subject device and predicate device are highly similar in their technical performance characteristics. Both achieve root canal length measurement accuracy within ±0.5 mm and use nickel-titanium (NiTi) files. Accessories such as contra-angle, file clamp, and lip clip are designed for sterilization prior to use, in line with standard infection control requirements. Both devices require the usage of a barrier sleeve on the hand piece body to prevent cross-contamination.

Some minor differences exist between the devices:

Power supply: the EnDrive control unit uses a NiMH battery at 12V, compared to the 7.4V Li-ion battery of the predicate.

User interface: EnDrive incorporates a touch screen interface with a single power button, while the predicate combines a touchscreen with additional physical buttons.

Physical dimensions differ slightly for both control unit and hand piece, but these variations do not alter function.

Performance ranges: EnDrive operates at 250-1000 rpm (vs. 150-1000 rpm) and 0.4-5.0 N•cm torque (vs. 0.6-3.9 N•cm). These ranges overlap and ensure equivalent clinical performance.

Charging method: EnDrive charges via cable connection between the control unit and hand piece, while the predicate supports wireless charging. Both methods have been demonstrated to be safe and effective.

Spray nozzle: EnDrive includes a nozzle for lubrication of the contra-angle, while the predicate also incorporates a spray nozzle; these differences are accessory-related and have no impact on performance.

Patient-contacting materials: EnDrive maintains direct patient contact only through the stainless-steel lip clip, while indirect patient contact may occur via the contra-angle and file clamp. Biocompatibility testing has been completed for the direct and indirect patient-contacting components in accordance with ISO 10993-1, -5, and -18.

Applied standards: minor variations exist in referenced biocompatibility and performance standards, but both devices comply with the relevant ISO and IEC standards for electrical, mechanical, and thermal safety, as well as EMC requirements.

Firmware updates: EnDrive supports software updates via Wi-Fi, while the predicate does not specify such a feature.

These differences are minor in nature, have been verified through bench testing and design validation, and do not raise new safety or effectiveness concerns.

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Non-Clinical and/or Clinical Tests Summary & Conclusions - 21 CFR 807.92(b)

Based on the bench test reports assessing the apex locator, motor speed and torque accuracies, the subject device is substantially equivalent based on the following:

The motor speed range for the subject device is 250-1000 rpm, which is within the range of the predicate device (150-1000 rpm)
The accuracy of the root apex locator function for the subject and predicate devices is ± 0.5mm
The torque is between 0.4 - 5.0 N cm for the subject device and is slightly different from that of the predicate (0.6 - 3.9 N cm), but this difference is minor and does not impact substantial equivalence between the two devices.

In addition to these key features that have been tested, biocompatibility, EMC, reprocessing, and device specific performance tests were conducted for the subject in accordance with the following standards:

ISO 10993-1:2018
ISO 10993-5:2009
ISO 10993-18:2020
ISO 10993-23:2021
IEC 60601-1:2020
IEC 60601-1-2:2020
IEC 62133-2:2017
ISO 14457:2017
ISO 17665-1:2006
ISO 17664-1:2021

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.