Endo Motor

K222548 · Shenzhen Perfect Medical Instruments Co., Ltd. · EKX · Apr 26, 2023 · Dental

Device Facts

• Record ID: K222548
• Device Name: Endo Motor
• Applicant: Shenzhen Perfect Medical Instruments Co., Ltd.
• Product Code: EKX · Dental
• Decision Date: Apr 26, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring 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. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Device Story

Cordless, battery-driven endodontic handpiece; integrates motor for canal enlargement and apex locator for length measurement. Input: electrical signals from file tip within root canal. Operation: motor rotates dental file at controlled speeds/torques; apex locator monitors file position via impedance/electrical sensing. Output: visual feedback of file position and motorized canal preparation. Used in dental clinics/hospitals by qualified dental personnel. Healthcare provider uses visual output to guide file depth and canal enlargement, preventing over-instrumentation and ensuring accurate canal preparation. Benefits: improved precision in root canal procedures and reduced risk of apical perforation.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via comparative root canal measurement tests, biocompatibility testing (ISO 10993-5, 10993-10), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and dental handpiece standards (ISO 14457).

Technological Characteristics

Battery-powered (Li-ion 3.7V) cordless handpiece. Materials conform to ISO 10993. Sensing principle: electrical impedance for apex location. Connectivity: none. Sterilization: autoclavable components (contra angle, lip hook, file clip, protective silicon cover). Software: moderate level of concern.

Indications for Use

Indicated for adult patients requiring root canal enlargement and preparation, and root canal length measurement. Contraindications not specified.

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)

Submission Summary (Full Text)

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April 26, 2023

Shenzhen Perfect Medical Instruments Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai, Shanghai 200122 CHINA

Re: K222548

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, LOY Dated: January 30, 2023 Received: January 30, 2023

Dear Jarvis Wu:

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 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.

# Michael E. Adjodha -S

Michael 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) K222548

Device Name Endo Motor

#### Indications for Use (Describe)

The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring 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.

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)

| <span style="font-family: sans-serif;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 510(k) Summary K222548

Document Date Prepared:2022/8/12

#### A. Applicant:

Name: Shenzhen Perfect Medical Instruments Co., Ltd.

Address: Room 102, Building A, Ruiji Factory, No. 3 Zaohekeng, Jixia Community, Nanwan Street,

Longgang District.Shenzhen, P.R. China. 518100

Contact Person: Kristy Mo

Tel: [phone]

Mail: [e-mail]

Submission Correspondent:

Primary contact: Mr. Jarvis Wu

Shanghai SUNGO Management Consulting Co., Ltd.

14th floor, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

Secondary contact: Mr. Raymond Luo

14th floor, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

## B. Device:

Proprietary Name: Endo Motor Common Name: Endodontic treatment motorized handpiece with built-in apex locator Model(s): ZR-Rap

#### Regulatory Information

Classification Name: Dental handpiece and accessories Classification: Class I Primary Product code: EKX Secondary Product Code: LQY Regulation Number: 878. 4200

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## C. Predicate device:

Manufacturer: Changzhou Sifary Medical Technology Co., Ltd. Device name: E-Connect S Endo Motor With Built-In Apex Locator 510(K) Number: K201993

(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)

## D. Indications use of the device:

The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring 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.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

### E. Device Description:

The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.

### F. Comparison with predicate device

Table 1 General Comparison

| Device | Proposed Device | Predicate device | Comparison |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Shenzhen Perfect Medical<br>Instruments Co., Ltd. | Changzhou Sifary<br>Medical Technology Co., Ltd. | - |
| 510K number | K222548 | K201993 | - |
| Device name | Endo Motor | E-connect S Endo Motor | - |
| Classification<br>Regulation | 21CRF 872.4200 | 21CRF 872.4200 | Same |
| Classification | Class I | Class I | Same |
| Product Code | EKX, LQY | EKX, LQY | Same |
| Common name | Endodontic treatment motorized<br>handpiece with built-in apex<br>locator | Endodontic treatment motorized<br>handpiece with built-in apex<br>locator | Same |
| Indications for use | The Endo Motor, model: ZR-Rap,<br>is a cordless endodontic treatment<br>motorized handpiece with root<br>canal measuring capability. It can<br>be used to enlarge canals while<br>monitoring the position of the file<br>tip inside the canal. It can be used<br>as a low-speed motorized<br>handpiece and device for<br>measuring canal length. This<br>device must only be used in<br>hospital environments, clinics or<br>dental offices by qualified dental<br>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 file<br>tip inside the canal. It can be used<br>as a low-speed motorized<br>handpiece and device for<br>measuring canal length. This<br>device must only be used in<br>hospital environments, clinics or<br>dental offices by qualified dental<br>personnel. | Same |
| Patient populations | Adult | Adult | Same |
| Anatomical sites | Root canal, softened<br>dentin | Root canal, softened<br>dentin | Same |
| Where used | Dental clinic, University<br>hospital and the other<br>clinical settings | Dental clinic, University<br>hospital and the other<br>clinical settings | Same |
| Energy used and/or<br>delivered | Li-ion battery (DC 3.7V) | Li-ion battery (DC 3.7V) | Same |
| Exterior Design | 28.2cm × 19.0cm × 6.2cm | 21.5cm × 17.5cm × 9cm | Similar |
| Performance 1 -<br>canal enlargement | 150rpm-650rpm<br>0.6N.cm-4N.cm | 120-1000 rpm<br>0.5N.cm-4N.cm | Different |
| Performance 2 -<br>apex locator | Accuracy of the root apex<br>locator function: -0.5mm | Accuracy of the root apex<br>locator function: -0.5mm | Same |
| | to +0.5mm for Apex position. | to +0.5mm for Apex position. | |
| Materials | Used materials conform | Used materials conform | Same |
| Biocompatibility | to ISO10993. | to ISO10993. | Same |
| Spray Nozzle | Spray nozzle (Oil injector) | Spray nozzle | Same |
| Compatibility<br>with environment<br>and other devices | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same |
| Sterility | Contra Angle, Lip Hook,<br>File clip, Protective silicon cove | Contra Angle, Lip Hook,<br>File clip, Insulating<br>Sleeve autoclavable. | Same |
| Electrical safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Mechanical safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Thermal safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Same |
| Radiation safety | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same |

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Shenzhen Perfect Medical Instruments Co., Ltd. Room 102, Building A, Ruiji Factory, No. 3 Zaohekeng, Jixia Community, Nanwan Street, Longgang District,Shenzhen, P.R. China. 518100

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### Different Analysis:

The rotation speed of Endo Motor is within the speed range of the predicate device, and it has passed performance test, no affect on safety or efficacy.

### G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and FDA Guidance:

- A 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
- A IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- A 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
- A IEC 80601-2-60: 2019 Medical Electrical Equipment - Part 2-60: Particular Requirements for Basic

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Safety and Essential Performance of Dental Equipment.

- > ISO 14457: 2017 Dentistry - Handpieces and motors
- > Moderate level of software documentation per the FDA Guidance for Software Contained in Medical Devices.
- A Reprocessing validation (i.e., cleaning, disinfection, and sterilization) per the FDA Guidance Document for Reprocessing Medical Devices in Healthcare Setting.
- A Comparative Root Canal Measurement Performance Test to evaluate the root canal length

## H. Clinical Test Conclusion

No clinical study is included in this submission.

### I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Endo Motor (Model: ZR-Rap) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201993.