Endo Motor

K203320 · Guilin Woodpecker Medical Instrument Co., Ltd. · EKX · May 10, 2021 · Dental

Device Facts

• Record ID: K203320
• Device Name: Endo Motor
• Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
• Product Code: EKX · Dental
• Decision Date: May 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the tip inside the canal.

Device Story

Cordless endodontic motorized handpiece; used in dental clinics/hospitals by dental professionals. Inputs: rotary instrument (dental file) position/torque data. Operation: motor drives file for canal enlargement; integrated apex locator measures canal length. Output: visual monitoring of file tip position within canal; adjustable torque/speed settings. Safety: automatic stop/reverse rotation upon reaching apical stop to prevent perforation. Benefits: enables precise canal preparation and length measurement, reducing risk of over-instrumentation.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5/10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software V&V (IEC 62304), usability (IEC 62366-1), packaging (ASTM D4169), dental performance (IEC 80601-2-60, ISO 14457), and sterilization validation (ISO 17665). Root canal measurement performance was verified via comparison testing.

Technological Characteristics

Cordless handpiece; PC/PBT blend housing; brushless micro-motor; 3.7V lithium battery; 6:1 contra-angle gear ratio. Connectivity: USB port. Sterilization: moist heat. Software: V&V per IEC 62304. Torque range: 0.4-5 Ncm; Speed: 100-1200 rpm.

Indications for Use

Indicated for patients in need of root canal surgery. Used for preparation and enlargement of root canals and measurement of canal length.

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

• Tri Auto ZX2 (K170275)

Reference Devices

• XSmart iQ (K161213)

Submission Summary (Full Text)

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May 10, 2021

Guilin Woodpecker Medical Instrument Co., Ltd. % Giselle Zhang Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K203320

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 Dated: April 13, 2021 Received: May 10, 2021

Dear Giselle Zhang:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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).

Sincerely,

For Michael Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203320

Device Name

Endo Motor

Indications for Use (Describe)

Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.

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

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 5. 510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

#### 5.1 Submitter Information

| Company: | Alex Wang |
|------------------------|---------------------------------------------------|
| | Registration & Certification |
| | GUILIN WOODPECKER MEDICAL |
| | INSTRUMENT CO., LTD |
| | Information Industrial Park, Guilin National High |
| | Tech Zone |
| | Guilin, Guangxi 541004 P.R. China |
| | Telephone: [phone] |
| | Fax: [phone] |
| | [e-mail] |
| Contact: | Giselle Zhang |
| | Regulatory Consultant |
| | Emergo Global Consulting, LLC |
| | 2500 Bee Cave Road, Building 1, Suite 300 |
| | Austin, Texas 78746 USA |
| | Telephone: [phone] |
| | Fax: [phone] |
| | [e-mail] |
| Date Summary Prepared: | March 29, 2021 |

### 5.2 Device Name and Regulatory Information

| Trade Name: | Endo Motor |
|----------------------|----------------------------------|
| Common Name: | Dental handpiece and accessories |
| Classification Name: | Dental |
| Review Panel: | Dental (DE) |
| Regulation: | 872.4200 |
| Class: | Class I |
| Product Code: | EKX |

# 5.3 Equivalence Claimed to PredicateDevice

The Endo Motor is equivalent to the Tri Auto ZX2 (K170275), manufactured by J. MORITA USA, INC.. XSmart iQ (K161213) is provided as a reference device.

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# 5.4 Device Description

The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.

## 5.5 Intended Use Statement

Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the tip inside the canal.

## 5.6 Non-Clinical Testing

To demonstrate substantial equivalence in safety and effectiveness of Endo Motor Series to the predicate device, Woodpecker completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Endo Motor Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and its substantial equivalence to the predicate device :

- Cytotoxicity testing per ISO 10993-5 Passed .
- Sensitization testing per ISO 10993-10 Passed ●
- Electrical safety testing per IEC 60601-1 Passed ●
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed ●
- Software verification and validation per IEC 62304/FDA Guidance - Met Requirements
- . Usability per IEC 62366-1 - Met specifications
- Shipping Containers and Systems Performance, per ASTM D4169 Demonstrates package integrity ● maintained
- Dental Performance Requirements, per IEC 80601-2-60 Passed Processing of Medical Device, per ISO ● 17664 - Passed
- Development, Validation and Routine Control of Sterilization Process, per ISO 17665-1 Passed Moist . Heat Sterilization, per ISO TS 17665-2 - Passed
- Dentistry - Handpieces and Motors, per ISO 14457 - Passed
- Performance Comparison Testing of Root Canal Measurement Passed ●

#### 5.7 Substantial Equivalence Discussion

Both Tri Auto ZX2 and Endo Motor Series are battery-driven handpieces with a motor, equipped with a chuck for holding rotary instruments such as a dental file. Both devices can be used for cutting and grinding teeth by transferring rotary movement to a rotary instrument attached to the head. Cutting and grinding of teeth can be done depending on switching/reversing the rotation direction. Rotation speed is acceleratedaccording to the user's preference, rotation control is based on torque detection, or pre-set time. These controls enable the cutting, grinding, enlargement, and preparation of root canals. Both devices can be used as an apex locator, and the measured value can be used for rotation control. Also both devices are intended to be sterilized prior touse.

The Tri Auto ZX2 can be used for the removal of extraneous materials such as gutta-percha points, and for professional mechanical tooth cleaning.

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The XSmart iQ is used as a reference device. As for the XSmart iQ, the Endo Motor series includes cordless motor hand-pieces, and both devices have a console. The Endo Radar Plus has integrated the display on the base but XSmart iQ is based on an Apple iPad Mini®. The motor parameters can be transferred, stored and displayed via the base on the Endo Radar Plus, but XSmart iQ uses iPad Mini® application (Endo iQ app).

| Table 5.1: Substantial Equivalence Discussion | | | |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Endo Motor, Ai- Motor | Endo Motor, Endo Radar Plus | Tri-Auto ZX2 K170275 (Primary) |
| Manufacturer | GUILIN WOODPECKER<br>MEDICAL INSTRUMENT<br>CO., LTD | GUILIN WOODPECKER<br>MEDICAL INSTRUMENT<br>CO., LTD | J. MORITA USA, INC. |
| Intended Use | Canal Enlargement Root<br>Canal Length Measurement | Canal Enlargement Root<br>Canal Length Measurement | Canal Enlargement Root<br>Canal Length Measurement |
| Indication for Use | Endo Motor, Ai- Motor is a<br>cordless endo motor with<br>root canal measurement<br>capability. It can be used as<br>a endo motor for<br>preparation and<br>enlargement of root canals,<br>or device for measuring<br>canal length. It can be used<br>to enlarge the canals while<br>monitoring the position of<br>the file tip inside the canal. | Endo Motor, Ai- Motor and<br>Endo Radar Plus are<br>cordless endodontic motor<br>with root canal<br>measurement capability. It<br>can be used as a endo motor<br>for preparation and<br>enlargement of root canals,<br>or device for measuring<br>canal length. It can be used<br>to enlarge the canals while<br>monitoring the position of<br>the file tip inside the canal. | The Tri Auto ZX2 device is<br>a cordless endodontic<br>treatment motorized<br>handpiece with root canal<br>measurement capability. It<br>can be used to enlarge<br>canals while monitoring the<br>position of the file tip<br>inside the canal. It can be<br>used as a low-speed<br>motorized handpiece and<br>device for measuring canal<br>length. |
| Target Population | Patients in need of root<br>canal surgery | Patients in need of root<br>canal surgery | Patients in need of root<br>canal surgery |
| Anatomical Sites | Root canal Softened dentin | Root canal Softened dentin | Root canal Softened dentin |
| Where Used | Dental Clinic<br>University<br>Hospital<br>The other clinical settings | Dental Clinic<br>University<br>Hospital<br>The other clinical settings | Dental Clinic<br>University<br>Hospital<br>The other clinical settings |
| Dimension | Motor Handpiece: 28 mm x<br>33.7 mm<br>x 199.2 mm | Motor Handpiece:<br>27.8 mm x 29 mm<br>x 212 mm | Motor Handpiece: 30 mm x<br>30 mm x<br>200 mm |
| Weight | 150g | 151g | 140g |
| User Interface | Four push buttons:<br>ON/OFF<br>Setting button<br>Adjusting button "+"<br>Adjusting button "-" | Push Button of Handpiece:<br>ON/OFF<br>Touch Button of Base:<br>"Power" button: Control<br>the power on or off.<br>"Auto Rev" button<br>"REV" button<br>"En-Ap" button<br>"SET" button<br>"SYSTEM" adjusting<br>button<br>"FILE" button<br>"TORQUE" button<br>"SPEED" button<br>"ANGLE" button | Four push buttons:<br>ON/OFF<br>Setting button<br>Adjusting button “+”<br>Adjusting button "-" |
| Materials of Motor<br>Handpiece | PC/PBT blend (PC-<br>Polycarbonate, PBT-<br>polybutylene terephthalate) | PC/PBT blend (PC-<br>Polycarbonate, PBT-<br>polybutylene terephthalate) | PC/PBT blend (PC-<br>Polycarbonate, PBT-<br>polybutylene terephthalate) |
| | lithium battery (3.7V) | 3.7 V) | |
| Charger Power Supply | AC100V-240V | AC100V-240V | AC100V-240V |
| Frequency of Supply<br>Voltage | 50Hz ~ 60Hz | 50Hz ~ 60Hz | 50Hz ~ 60Hz |
| Components | Measuring wire<br>File clip Lip hook<br>Touch probe<br>Silicon Cover<br>Tester<br>Spray Nozzle | Measuring wire<br>File clip Lip hook<br>Touch probe<br>Silicon Cover<br>Tester<br>Spray Nozzle | Tester<br>Spray Nozzle |
| Safety Mechanism | Automatically stops or<br>reversely rotates as soon as<br>the file reaches the apical<br>stop, so as to prevent<br>perforation. | Automatically stops or<br>reversely rotates as soon as<br>thefile reaches the apical<br>stop, so as to prevent<br>perforation. | Auto Torque Reverse:<br>The OTR (Optimum<br>Torque Reverse) function<br>enables the file to reverse<br>its rotational direction upon<br>reaching a certain torque.<br>After rotating in reverse by<br>90 degrees, the file returns<br>to the cutting direction. |
| Battery Indicator | When the blue indicator on<br>the charging base flashes, it<br>is charging.<br>When the motor handpiece<br>is fully charged, the blue<br>indicator on the charging<br>base would be always on. | Motor hand-piece battery<br>level is displayed on base.<br><br>The battery sign on the base<br>screen is full to<br>indicate the fully charged<br>state.<br>The battery sign on the<br>base screen is only 2/3 to<br>indicatethe remaining<br>battery power is about 70%.<br>The battery sign on the base<br>screen is only 1/3 to<br>indicatethe remaining<br>battery power is about 30%.<br>The battery sign on the base<br>screen is blank to indicate<br>the battery is very low,<br>please charge in time.<br>When charging, the screen<br>display panel green power<br>icon will scroll display,<br>when the battery power<br>sign no longer scroll<br>display, indicating that the<br>battery was fully charged. | The orange light indicates<br>charging.<br>The green light indicates<br>full charge. |
| Torque Range | 0.4 Ncm ~ 5 Ncm | 0.4 Ncm ~ 5 Ncm | 0.4 Ncm ~ 4 Ncm |
| Rotate Speed | 100 rpm~1200 rpm<br>(File in rotary mode) | 100 rpm~1200 rpm<br>(File in rotary mode) | 100 rpm~1000 rpm<br>(File in rotary mode) |
| Adjustability of Speed<br>and Torque | 0.5 Torque setting(Ncm)<br>50 speed steps | 0.5 Torque setting (Ncm)<br>50 speed steps | 0.2 Torque setting(Ncm)<br>75 speed steps |
| Micro Motor | Brushless | Brushless | Brush |
| USB Ports | Yes | Yes | Yes |
| Contra Angle<br>Attachments | 6:1 Contra Angle (Model:<br>CA161) | 6:1 Contra Angle (Model:<br>CA161) | Morita Contra Angle<br>Specific (Exclusive) to<br>TriAuto ZX2 |
| Primary Contra Angle<br>Gear Ratio | 6:1 | 6:1 | 6:1 |
| Operation Mode | Continuous operation | Continuous operation | Continuous operation |
| Biocompatibility | Conforms to 10993 | Conforms to 10993 | Conforms to 10993 |
| | Standards | Standards | Standards |
| Sterilization | End User (Moist Heat) | End User (Moist Heat) | End User (Moist Heat) |
| Electrical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Conform to IEC 60601-1 |
| Mechanical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Conform to IEC 60601-1 |
| Thermal Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Conform to IEC 60601-1 |
| EMC Safety | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 |

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#### 5.8 Conclusion

The Endo Motor Series has the same intended use and the same or similar technological characteristics and functionality as the predicate, and therefore is substantially equivalent to the predicate device. The differences are minor and supported by the reference device to demonstrate they do not raise new questions of safety and effectiveness as compared to the predicate device.