Endo Motor

K220829 · Foshan Coxo Medical Instrument Co., Ltd. · EKX · May 18, 2023 · Dental

Device Facts

• Record ID: K220829
• Device Name: Endo Motor
• Applicant: Foshan Coxo Medical Instrument Co., Ltd.
• Product Code: EKX · Dental
• Decision Date: May 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP: 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 handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-Smart-mini: The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Device Story

Endo Motor is a low-speed motorized handpiece for root canal preparation and length measurement. Input: manual control via keys/LCD interface; file tip position signals (for apex locator models). Operation: motor drives NiTi files; apex locator monitors file tip position via impedance sensing. Output: visual display of speed, torque, working mode, and apex position on LCD. Used in dental clinics/hospitals by dentists. Provides torque control (auto-reverse/stop) to prevent file breakage; assists in canal enlargement and length determination. Benefits: improved procedural accuracy and safety during endodontic treatment.

Clinical Evidence

No clinical study included. Bench testing only. Accuracy testing verified apex position measurement within ±0.5mm. Biocompatibility testing (ISO 10993-5, -10, -11, -23) and electrical/mechanical safety testing (IEC 60601-1, IEC 80601-2-60) performed.

Technological Characteristics

Portable, battery-powered (Li-ion) motorized handpiece. Materials: Copper, 304 Stainless steel, PI plastic, PPSU. Features: LCD display, torque control, auto-reverse, apex locator (impedance-based). Connectivity: Bluetooth (C-SMART-I PILOT), wireless charging (C-SMART-MINI AP, C-Smart-mini). Sterilization: Steam autoclave for contra-angle and accessories. Software: Moderate level of concern.

Indications for Use

Indicated for adult patients requiring endodontic treatment, specifically root canal preparation and/or canal length measurement. Must be used by qualified dental personnel in clinical or hospital settings.

Regulatory Classification

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.

Predicate Devices

• E-connect S Endo Motor with built-in Apex Locator (K201993)

Reference Devices

• XSmart iQ (K161213)

Submission Summary (Full Text)

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May 18, 2023

Foshan COXO Medical Instrument Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA

Re: K220829

Trade/Device Name: Endo Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I. reserved Product Code: EKX, LQY Dated: April 24, 2023 Received: April 24, 2023

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

# Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. 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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# Indications for Use

510(k) Number (if known) K220829

Device Name Endo Motor

### Indications for Use (Describe)

C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:

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 canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

C-Smart-mini:

The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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The assigned 510(k) Number:

# 510(k) Summary

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.

- 1. Date of Preparation:2023/05/17
- 2. Sponsor Identification

### Foshan COXO Medical Instrument Co., Ltd.

BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226 Guangdong, China.

Contact Person: Yongjian Zheng Position: Legal Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. 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, 102401, China

Tel: [phone] Fax: [phone] Email: information(@believe-med.com

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#### 4. Identification of Proposed Device

Trade Name: Endo Motor Common Name: endodontic treatment motorized handpiece/root canal apex locator

Regulatory Information Classification Name: Handpiece, Direct Drive, Ac-Powered Classification: 1 Primary Product Code: EKX Regulation Number: 872.4200 Secondary Product Code: LQY Review Panel: Dental

Indication for use Statement:

### C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:

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 handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

### C-Smart-mini:

The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Device Description:

### C-SMART-I PRO

The Endo Motor device C-SMART-I 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 the adapter. 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, calibration and functional check of the apex locator.

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 handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Endo Motor device C-SMART-I PRO is intended to be sterilized prior to use.

The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PRO is Nickel titanium (NiTi). These files are not included in the submission.

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There are three working modes as:

M1: Apex locator only.

M2: Motor only.

M3: (Dual mode) Motor with apex location function.

### C-SMART-I PILOT

The Endo Motor device C-SMART-I PILOT 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 the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of function check, calibration, factory reset and can connect handpiece to control unit via Bluetooth.

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 handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Endo Motor device C-SMART-I PILOT is intended to be sterilized prior to use.

The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PILOT 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.

### C-SMART-MINI AP

The Endo Moto device C-SMART-MINI AP 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 the adapter. LCD displays parameters such as speed, torque, apex position, etc. Users can also set and modify by keys, and provide design of functional check, calibration, set dominant hand and factory reset.

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 handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Endo Motor device C-SMART-MINI AP is intended to be sterilized prior to use.

The material composition of root canal files that can be used with the Endo Motor device C-SMART-MINI AP is Nickel titanium (NiTi). These files are not included in the submission.

There are three working modes as:

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Endo motor: Prepare the root canal, without apex locator function. Apex Locator: Measure the length of the root canal, without motor function. Multi-function: Measuring the length while root canal preparation.

### C-Smart-mini

The Endo Motors device C-Smart-mini is a low-speed rotating oral equipment mainly used for root canal preparation. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, rotary files program, etc. Users can also set and modify by keys, and provide design of calibration and screen display for right- or left-handed user.

The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Endo Motor device C-Smart-mini is intended to be sterilized prior to use.

The material composition of root canal files that can be used with the Endo Motor device C-Smart-mini is Nickel titanium (NiTi). These files are not included in the submission.

#### Identification of Predicate Device(s) న్.

Predicate Device K201993 E-connect S Endo Motor with built-in Apex Locator Changzhou Sifary Medical Technology Co., Ltd.

Reference Device: 510(k) Number: K161213 Product Name: XSmart iQ Manufacturer: Dentsply Sirona

- 6. 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:

- > ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- > ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic > toxicity.

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- > ISO 10993-23 First edition 2021-01Biological evaluation of medical devices - Part 23: Tests for irritation
- > IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic > Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
- > IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
- ISO 14457:2017 Dentistry Handpieces and motors; >
- A IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications;
- > IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- > ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
- > FCC 47 CFR, Part 15, Subpart C, Section 15.247, 15.207 &15.209
- TIR69:2017/(R2020) Technical Information A AAMI Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
- IEC 62304:2015 Medical device software Software life cycle processes. >
- IEC 62366-1:2020 Medical devices Part 1: Application of usability engineering to medical > devices.
- Bluetooth and Wireless Charging testing. A
- > Accuracy Testing (Internal test methods to demonstrate the apex position measurement accuracy of ±0.5mm).
- A Software documentation for a moderate level of concern per FDA Guidance Document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".
- > Cleaning, Disinfection and Sterilization for components of the proposed device according to the FDA Guidance Document: "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
- > ISO 17665-1:2016 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- > ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

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#### 8. Substantially Equivalent (SE) Comparison

| Item | Proposed Device(s) | | | | Predicate Device(s)<br>K201993 | Reference Device<br>K161213 | Remark |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Device name | Endo Motor | | | | E-connect S Endo Motor with<br>built-in Apex Locator | XSmart iQ | / |
| Device model | C-SMART-I<br>PRO | C-SMART-I<br>PILOT | C-SMART-MINI<br>AP | C-Smart-mini | E-connect S | XSmart iQ | / |
| Classification<br>Regulation | 21CFR 872.4200 | | | | 21CFR 872.4200 | 21CFR 872.4200 | SAME |
| Classification | Class I | | | | Class I | Class I | SAME |
| Product Code | EKX/LQY | | | | EKX/LQY | EBW | Same with the<br>Predicate<br>Device |
| Common Name | endodontic treatment motorized handpiece/<br>root canal apex locator | | | | endodontic treatment motorized<br>handpiece/<br>root canal apex locator | Dental hand-piece and<br>accessories | Same with the<br>Predicate<br>Device |
| Indications<br>for use | C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:<br>The Endo Motor device is an endodontic treatment motorized handpiece<br>with root canal measurement capability. It can be used to enlarge the canals<br>while monitoring the position of the file tip inside the canal. It can be used<br>as a low-speed motorized handpiece and device for measuring canal length.<br>This device must only be used in hospital environments, clinics or dental<br>offices by qualified dental personnel. | | | | E-connect S is a cordless<br>endodontic treatment motorized<br>handpiece with root canal<br>measuring capability. It can be<br>used to enlarge canals while<br>monitoring the position of the<br>file tip inside the canal. It can | XSmart iQ is a cordless<br>motor hand-piece with torque<br>control used for driving files<br>in both reciprocating and<br>continuous rotation mode<br>during an endodontic<br>procedure. | SAME<br>The root canal<br>measurement<br>capability is<br>only same with<br>the Predicate<br>Device. |
| | C-Smart-mini: | | | | be used as a low-speed | | |
| | The Endo Motor device is an endodontic treatment motorized handpiece. It<br>can be used to enlarge the canals. It can be used as a low-speed motorized<br>handpiece. This device must only be used in hospital environments, clinics<br>or dental offices by qualified dental personnel. | | | | motorized handpiece and device<br>for measuring canal length. This<br>device must only be used in<br>hospital environments, clinics<br>or dental offices by qualified<br>dental personnel. | | |
| Patient<br>populations | Adult | | | | Adult | Adult | SAME |
| Anatomical<br>sites | Root canal, softened dentin | | | | Root canal, softened dentin | Root canal, softened dentin | SAME |
| Where used | Dental clinic, University hospital and the other clinical settings | | | | Dental clinic, University<br>hospital and the other clinical<br>settings | Dental clinic, University<br>hospital and the other<br>clinical settings | SAME |
| Technical Specifications | | | | | | | |
| Energy<br>used<br>and/or delivered | Li-ion battery<br>(DC 7.4V) | Li-ion battery<br>(Control unit:<br>DC7.4V<br>Motor handpiece:<br>DC3.7V) | Li-ion battery<br>(DC 3.7V) | Li-ion battery<br>(DC 3.7V) | Li-ion battery (DC 3.7V) | Lithium ion battery: 3.6V | Difference<br>(1) |
| Charger Power<br>Supply | AC 100-240V<br>50-60 Hz | AC 100-240V<br>50-60 Hz | AC 100-240V<br>50-60 Hz | AC 100-240V<br>50-60 Hz | Unknown | AC 100-240 Volts<br>50-60 Hz | Same with the<br>Reference<br>Device |
| Display | LCD<br>Control<br>unit display with | LCD Control unit<br>display<br>with | LCD Motor<br>Handpiece | LCD Motor<br>Handpiece | OLED Motor Handpiece<br>display with button | iPad Mini® display with<br>iPad Mini® application | Difference<br>(2) |
| | membrane<br>keypad | touch screen and<br>button | display with<br>button | display with<br>button | | (Endo iQ app) | |
| | LCD screen for<br>visual selection<br>of<br>parameters<br>such as speed,<br>torque, working<br>mode, apex<br>position, etc. | LCD screen for<br>visual selection<br>of<br>parameters<br>such as speed,<br>torque, working<br>mode, apex<br>position, etc. | LCD screen for<br>visual selection<br>of parameters<br>such as speed,<br>torque, apex<br>position, etc. | LCD screen for<br>visual selection<br>of parameters<br>such as speed,<br>torque, rotary<br>files program,<br>etc. | OLED screen for visual<br>selection of parameters such as<br>speed, torque, files program,<br>apex position, etc. | iPad Mini® application<br>(Endo iQ app) with<br>predefined torque and speed<br>settings. | |
| | Corded motor<br>hand-piece | Cordless motor<br>hand-piece | Cordless motor<br>hand-piece | Cordless motor<br>hand-piece | Cordless motor hand-piece | Cordless motor hand-piece | Difference<br>(3) |
| Features | Continuous rotation and reciprocating movement | | | | Continuous rotation and<br>reciprocating movement | Continuous rotation and<br>reciprocating movement | SAME |
| | root canal<br>measurement | root canal<br>measurement | root canal<br>measurement | N/A | root canal measurement | N/A | Same with the<br>Predicate<br>Device |
| Operation Mode | M1 mode: Apex<br>locator only.<br>M2 mode:<br>Motor only.<br>M3 mode: (Dual<br>mode) Motor<br>with apex<br>location<br>function. | Endo motor<br>mode: root canal<br>preparation.<br>Apex locator<br>mode: root canal<br>length<br>measurement.<br>Multi-function<br>mode: undertake<br>root canal<br>measurement and | Endo motor<br>mode: Prepare<br>the root canal,<br>without apex<br>locator function.<br>Apex Locator<br>mode: Measure<br>the length of the<br>root canal,<br>without motor<br>function.<br>Multi-function | Endo motor<br>mode | Endo Motor mode/<br>Apex mode | Not Available | Difference<br>(4) |
| | | preparation . | mode: Measuring<br>the length while<br>root canal<br>preparation. | | | | |
| Safety<br>Mechanisms | | During operation when the load reaches the preset torque limit value , the<br>motor will automatically rotate in the reverse direction . | | | Unknown | XSmart iQ has safety<br>mechanisms for preventing<br>the file being over-torqued<br>while in operation by<br>implementing a torque<br>control feature that willreverse the direction of the<br>file if the torque exceeds a<br>predefined limit. | Same with the<br>Reference<br>Device |
| Exterior Design | 136.1 x 135.6 x<br>118.5mm(Contr<br>ol unit)<br>201.4 x 32.9<br>x21.4mm (Motor<br>handpiece<br>include Contra<br>angle) | 201.4 x 111.2 x<br>64.6mm(Control<br>unit)<br>201.8 x 31.4<br>x28mm (Motor<br>handpiece include<br>Contra angle) | 209.2 x 33.8 x<br>30mm (Motor<br>handpiece<br>include Contra<br>angle)<br>66 x φ 90.4mm<br>(Battery Charger) | 217.45 x 28.18<br>x 26mm<br>(Motor<br>handpiece<br>include Contra<br>angle)<br>39.6 x φ 80mm<br>(Charging<br>Base) | 21.5cm×17.5cm×9cm | 206 mm X 24.6 mm X 24.8<br>mm | Difference<br>(5) |
| Speed | 150-650rpm | 150-1000rpm | 150-600rpm | 125-625rpm | 120-1000 rpm | 1200 - 5100 RPM (in rotary<br>mode) | Difference<br>(6) |
| Torque | 0.6-5.2 N.cm | 0.6-3.9 N.cm | 0.6-3.9 N.cm | 0.6-3.9 N.cm | 0.5N・cm-4N・cm | 50-510 gram-cm | Difference<br>(7) |
| | | | | | | | (7) |
| Accuracy of the<br>root apex locator<br>function | $\pm0.5mm$ | $\pm0.5mm$ | $\pm0.5mm$ | No root apex<br>locator<br>function | -0.5mm to+0.5mm for Apex<br>position | N/A | Same with the<br>Predicate<br>Device |
| Spray Nozzle | Spray nozzle | | | | Spray nozzle | Spray nozzle | SAME |
| Bluetooth | No Bluetooth | Bluetooth 4.0 low<br>energy<br>(communication<br>between the<br>control unit and<br>motor handpiece) | No Bluetooth | No Bluetooth | No Bluetooth | Bluetooth 4.0 low energy<br>(communication between the<br>Apple iPad and motor<br>handpiece) | Difference<br>(8) |
| Wireless charging | N/A | Wireless charging | | | N/A | N/A | Difference<br>(9) |
| Sterility | Contra angle,<br>File clip , Lip<br>hook<br>and<br>lighting device<br>are sterilized<br>with steam<br>sterilization<br>process. | Contra angle, File<br>clip and Lip hook<br>are sterilized with<br>steam<br>sterilization<br>process. | Contra angle,<br>File clip and Lip<br>hook<br>are device<br>are sterilized with<br>steam<br>sterilization<br>process. | Contra angle<br>and lighting<br>device are<br>sterilized with<br>steam<br>sterilization<br>process. | Contra Angle, Lip Hook, File<br>clip, Insulating<br>Sleeve autoclavable. | Contra Angle are sterilized | Same with the<br>Predicate<br>Device |
| Patient<br>Contacting<br>Materials | Contra angle:<br>Copper and 304<br>Stainless steel;<br>File clip: Plastic<br>PI and 304<br>Stainless steel;<br>Lip hook: 304<br>Stainless steel;<br>Lighting device:<br>Plastic PPSU | Contra angle:<br>Copper and 304<br>Stainless steel;<br>File clip: Plastic<br>PI and 304<br>Stainless steel;<br>Lip hook: 304<br>Stainless steel | Contra angle:<br>Copper and 304<br>Stainless steel;<br>File clip: Plastic<br>PI and 304<br>Stainless steel;<br>Lip hook: 304<br>Stainless steel | Contra angle:<br>Copper and<br>304 Stainless<br>steel;<br>Lighting<br>device: Plastic<br>PPSU | Used materials conform<br>to<br>ISO10993. | Used materials conform to<br>ISO10993. | Difference<br>(10) |
| Applied Standards: | | | | | | | |
| Biocompatibility | ISO 10993-5 | | | | ISO 10993-5 | ISO 10993-5 | Same with the<br>Predicate<br>Device. |
| | ISO 10993-10 | |…