The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

Device Description

The Dental Electrical Motor iRoot Pro 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 batteries and charged by USB interface. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization and calibration. The product also provides a complete rotation mode and root canal measurement mode, which can be stored in memory, and provides a key functional mode for users to use quickly.

The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

The Dental Electrical Motor iRoot Pro is intended to be sterilized prior to use.

There are four working modes as:

Mode: Only endo motor function enabled;

Mode: Endo motor and apex locator work independently, when the file reaching theapical, the apex locator only plays the role of warning and display, will not interfere with the rotation of endo motor, the motor will not stop and reverse when the file reach the apical.

Mode: In this mode, the motor will automatically rotate, stop, reverse depends on the length of the root canal measured by the apex locator.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "Dental Electrical Motor iRoot Pro." This type of document is for market clearance based on substantial equivalence to a predicate device, and it does not typically contain detailed information about acceptance criteria and specific study results in the same way a clinical trial report or a performance study for a novel device would.

However, it does mention non-clinical tests performed and some performance claims. Based on the provided text, here's an attempt to extract and infer information about acceptance criteria and proofs, acknowledging the limitations of a 510(k) summary for this level of detail:

General Conclusion from the Document:

The device "Dental Electrical Motor iRoot Pro" was found to be Substantially Equivalent (SE) to its predicate device, Tri Auto ZX2 (K170275), based on non-clinical testing and comparison of technical specifications. No clinical studies were included in this submission (Section 7).

Specific Information Regarding Acceptance Criteria and Proof:

Since this is a 510(k) summary, the "acceptance criteria" are primarily framed around demonstrating substantial equivalence to a predicate device, rather than meeting novel performance thresholds established through extensive clinical trials. The "proof" relies heavily on non-clinical testing and comparison.

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, test-result-oriented table. Instead, it compares the proposed device's specifications to those of the predicate device, implying that equivalence in these specifications serves as the "acceptance." The key performance metric mentioned is the accuracy of the root apex locator function.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Proposed Device)
Root Apex Locator Accuracy: -1.5mm to +0.5mm for Apex position (Matching Predicate)	-1.5mm to +0.5mm for Apex position (Stated as "SAME" to predicate)
Speed: 100-1000 rpm (Matching Predicate)	100-1000 rpm (Stated as "SAME" to predicate)
Torque: 4 N.cm (Predicate)	0.1-4.0 N.cm (Stated as "SAME" to predicate, indicating range includes predicate's fixed value)
Sterility: Lip clip, contra angle autoclavable; central unit/lip hook cable use FDA-cleared barrier sleeve and intermediate level disinfected.	Lip clip, and contra angle are autoclavable. Central unit and lip hook cable are covered with an FDA cleared barrier sleeve and intermediate level disinfected. (Stated as "SAME" to predicate's parts, and additional details for non-autoclavable parts)
Biocompatibility: Compliant with ISO 10993-5, -10, -11	Compliant with ISO10993-5, ISO10993-10, ISO10993-11 (Stated as "SAME" applied standards)
Electrical Safety: Compliant with IEC 60601-1	Compliant with IEC60601-1 (Stated as "SAME" applied standards)
EMC: Compliant with IEC 60601-1-2	Compliant with IEC60601-1-2 (Stated as "SAME" applied standards)
Performance (General): Compliant with IEC 80601-2-60, ISO 14457	Compliant with IEC 80601-2-60, ISO 14457 (Stated as "SAME" applied standards)
Software Performance: Demonstrated moderate level of concern per FDA guidance	Software documentation submitted for moderate level of concern, indicating compliance.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for specific tests. "Non clinical tests were conducted to verify that the proposed device met all design specifications." The document mentions "apex locator measuring accuracy performance" testing but does not provide details on the sample size (e.g., number of measurements, number of simulated canals).
Data Provenance: The document does not specify the country of origin for the non-clinical test data. It's likely from the manufacturer's testing facilities in China (ChangZhou BoMedent Medical Technology Co., Ltd., China). The data is retrospective as it was conducted prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided: For non-clinical performance tests (like apex locator accuracy on a test setup or engineering standards compliance), human expert consensus in the traditional sense (e.g., for image interpretation) is not typically used to establish ground truth. The ground truth for such tests is based on established metrology and engineering principles. The document does not mention any expert involvement in establishing ground truth for these non-clinical tests.

4. Adjudication method for the test set

Not Applicable / Not Provided: As no human expert readers or reviewers are mentioned for assessing performance, no adjudication method would be relevant or provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No: The document explicitly states: "No clinical study is included in this submission" (Section 7). Therefore, no MRMC study or AI assistance evaluation was performed or submitted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes (for the Apex Locator Function): The "Apex Locator Performance Testing to verify the apex locator measuring accuracy performance" (Section 6.i) is a standalone performance test of the device's accuracy in measuring root canal length. While not an "algorithm" in the sense of AI, it represents the device's intrinsic function without human interpretation. The reported performance is -1.5mm to +0.5mm for Apex position.

7. The type of ground truth used

Engineering/Metrological Ground Truth: For the "Apex Locator Performance Testing," the ground truth would have been established through precise measurements on a phantom or cadaveric teeth model using established methods, often involving micrometers, radiovisiography, or direct visualization after sectioning, to determine the actual apical foramen position. For other non-clinical tests (e.g., electrical safety, EMC), the ground truth is defined by compliance with the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set

Not Applicable / Not Provided: This device is a traditional electro-mechanical dental instrument, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not Applicable / No Training Set: As it's not an AI/ML device, there is no training set and therefore no ground truth established for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 30, 2020

ChangZhou BoMedent Medical Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. R912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 CHINA

Re: K191276

Trade/Device Name: Dental Electrical Motor iRoot Pro Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EKX. LOY Dated: May 29, 2020 Received: June 1, 2020

Dear Ray Wang:

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 (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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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

510(k) Number (if known) K191276

Device Name Dental Electrical Motor iRoot Pro

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)

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This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K191276

1. Date of Preparation: June 30, 2020
1. Sponsor Identification

ChangZhou BoMedent Medical Technology Co., Ltd.

No.9 Changyang Road, West Taihu Science and Technology Industrial Park, ChangZhou, JiangSu 213000, China

Contact Person: Lily Zhang Position: Quality Supervisor Tel: +86-0519-88991980 Fax: +86-0519-88991980 Email: qm@bome-dent.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

Tel: +86-18910677558 Fax: +86-10- 56335780 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Dental Electrical Motor iRoot Pro Common Name: Dental Handpiece and Accessories Model(s): iRoot Pro

Regulatory Information Classification Name: Dental Handpiece and Accessories Classification: 1 Product Code: EKX/LQY Regulation Number: 21 CFR 872.4200 Review Panel: Dental;

Indications for Use Statement:

The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

Device Description

The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

The Dental Electrical Motor iRoot Pro is intended to be sterilized prior to use.

There are four working modes as:

Mode: Only endo motor function enabled;

Mode: Endo motor and apex locator work independently, when the file reaching theapical,

the apex locator only plays the role of warning and display, will not interfere with the rotation of endo motor, the motor will not stop and reverse when the file reach the apical.

Mode: In this mode, the motor will automatically rotate, stop, reverse depends on the length of the root canal measured by the apex locator.

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The chuck of proposed device needs to be used with the file in accordance with Type 1 in ISO 1797-1, the diameter of chuck interface is @ 1.5.

The lubricant to be used with the contra angle is "DO-ALL Dental Handpiece Lubricant" manufactured by ProDrive Systems Inc., which has been cleared as K073353.

న. Identification of Predicate Device(s)

Primary Predicate Device: 510(k) Number: K170275 Product Name: Tri Auto ZX2 Manufacturer: J. Morita USA, Inc.

Reference Device: 510(k) Number: K153285 Product Name: EMS-200 Manufacturer: Meta Systems Co., Ltd.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for a. basic safety and - essential performance

IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic b. Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests

C. ISO 14457:2017 Dentistry - Handpieces and motors
ISO 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for the d. basic safety and essential performance of dental equipment

ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro e. cytotoxicity.

f. ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity

Cleaning, Intermediate Level Disinfection, and Sterilization of the components of the g. subject device per the FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO 17665-2. In addition, disposable barrier sleeve anti-contamination and ingress verification testing

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was conducted.

Software documentation for moderate level of concern per the FDA Guidance Document "Guidance h. for the Content of Premarket Submissions for Software Contained in Medical Devices."
Apex Locator Performance Testing to verify the apex locator measuring accuracy performance i.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Table 1 Comparison of Technology CharacteristicsJ
-------------------------------------------------------

Item	Proposed Device(s)	Predicate Device(s)	Reference Device	Remark
Device name	Dental Electrical MotoriRoot Pro	Tri Auto ZX2	EMS-200	/
Classification Name	endodontic treatment motorizedhandpiece/root canal apex locator	endodontic treatment motorized handpiece/root canal apex locator	endodontic treatment motorized handpiece	SAME
Product Code	EKX/LQY	EKX/LQY	EKX	SAME
Regulation Number	872.4200	872.4200	872.4200	SAME
ComparisonStatement	The proposed device has same classification information as the predicate device.			SAME
Intended Use	The Dental Electrical Motor iRootPro is a cordless endodontic treatmentmotorized handpiece with root canalmeasurement capability. It can beused to enlarge canals whilemonitoring the position of the file tipinside the canal. It can be used as alow-speed motorized handpiece anddevice for measuring canal length.	The Tri Auto ZX2 device is a cordlessendodontic treatment motorized handpiecewith root canal measurement capability. Itcan be used to enlarge canals whilemonitoring the position of the file tip insidethe canal. It can be used as a low speedmotorized handpiece and device formeasuring canal length.	The EMS-200 is a dental device whichcombines in a single LCD unit an endomotor which ablates the tooth to expandthe root canal, a dental obturator to filland pressurize various shaped packingelements and an electronic apex locatorwhich assists the operator the location ofthe front tip in the root canal, for use bytrained dental professionals.	SAME
Usage	Prescription Use	Prescription Use	Prescription Use	SAME
ComparisonStatement	The proposed device has same intended use as the predicate device.			SAME
Technical Specifications
Energy used and/or	Li-ion battery (DC 3.7V)	Li-ion battery (DC 3.7V)	DC 12 V	SAME
delivered
Dimension	280 x 25 x 26mm(central unit includecontra angle)123 x 61 x81mm (battery charger)	30 mm x 30mm x 200 mmCharger: 85 mm x 85mm x 75 mm	148.1 mm x 187.6 mm x 45 mm	SIMILAR
Speed	100-1000 rpm	100-1000 rpm	250-800 rpm	SAME
Gear Ration	16:1	Not Available	16:1	SAME
Torque	0.1-4.0 N.cm	4 N.cm	0.6-5.0 N.cm	SAME
Accuracy of the rootapex locator function	-1.5mm to+0.5mm for Apex position	-1.5mm to+0.5mm for Apex position	-0.5mm to +0.5mm	SAME
Spray Nozzle	Spray nozzle	Spray nozzle	Not Available	SAME
Sterility	Lip clip, andcontra angle are autoclavable.The central unit and lip hook cable arecovered with an FDA cleared barriersleeve and intermediate leveldisinfected.	File holder, contrary electrode, and contraAngle are autoclavable.	Not Available	SAME
Feature	Canal measurement, alarm, canallength indicator	Canal measurement, alarm, canal lengthindicator	Canal measurement	SAME

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Operation Mode	R	Mode: Only apex locatormeasurement function enabled.	EMR mode: This mode is for canalmeasurement, the motor does not run in thismode.	Not Available
	M	Mode: Only endo motor functionenabled;	CW mode: The motor rotates for forward360, torque reverse and other functions canbe used.	SAME
	MR	Mode: Endo motor and apexlocator work independently, when thefile reaching the apical, the apexlocator only plays the role of warningand display, will not interfere with the	OGP mode: The OGP (Optimum Glide Path)function is used for canal negotiation andmaking the glide path.
			OTR mode: The OTR (Optimum TorqueReverse) function is used for canal shaping.
			CCW Mode: The motor rotates


	rotation of endo motor, the motor willnot stop and reverse when the filereach the apical.Image: MR logoMode: In this mode, the motorwill automatically rotate, stop, reversedepends on the length of the rootcanal measured by the apex locator.	counterclockwise direction only.
Principle of operation	Electrical motor drives the rotating offile equipped on the rotating toaccomplish it's indication for use.And the software control theparameter and method of rotating.	Electrical motor drives the rotating of fileequipped on the rotating to accomplish it'sindication for use. And the software controlthe parameter and method of rotating.	The Motor rotates the motor-operatedfile(Ni-Ti file) by pressing the operationbutton on the micro-motor handpiecewhich expands or shapes the root canal byusing the rotating power of the electric file(Ni-Ti file).Micro signals consisting of dualfrequencies coming from the main unitreturn to where they are sent aftertravelling along the electric circuit that iscomposed of 'main unit - probe cord - fileholder-file - patient - lip holder -probecord'.Pack handpiece provides instantaneousheating and cooling of the heat pluggerwith precisely controlled temperature andtiming.FILL handpiece is designed to inject	SAME

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Patient ContactingMaterials	Silica rubber and 304 stainless steel	Not Available	warmed Gutta percha that is speciallyformulated into the root canal directly.Silica rubber, stainless steel	Difference
ComparisonStatement:	The proposed device has the same main specifications with the predicate device but only minor difference in dimension, which caused bydifferent appearance design and do not effect the performance.The Patient contacting materials of predicate device could not be identified, so it considered as difference. For this difference, thebiocompatibility tests as ISO 10993 series standards have been conducted, the test results shown that the patient contacting materials ofproposed could not causes safety concerns.
Applied Standards:
Biocompatibility	ISO10993-5&ISO10993-10&ISO10993-11	ISO10993-5&ISO10993-10&ISO 10993-11	ISO10993-10	SAME
	Electrical Safety	IEC60601-1	IEC60601-1	IEC60601-1
EMC	IEC60601-1-2	IEC60601-1-2	IEC60601-1-2	SAME
Performance	IEC 80601-2-60ISO 14457	ISO 14457	ISO 14457	SAME
	ComparisonStatement	The proposed probe has same applied Standards with the predicate device.

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Substantially Equivalent (SE) Conclusion

The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.

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.