EQ-PEX

K210789 · Meta Systems Co., Ltd. · LQY · Oct 20, 2021 · DE

Device Facts

• Record ID: K210789
• Device Name: EQ-PEX
• Applicant: Meta Systems Co., Ltd.
• Product Code: LQY · DE
• Decision Date: Oct 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.

Device Story

EQ-PEX is an electronic apex locator used by dental professionals to determine root canal working length. The device consists of a main body, probe cord, lip hook, and file holders. It operates by measuring the impedance of two different frequencies as a stainless steel file is inserted into the root canal. The device tracks the file position and displays the measurement via a number and graph on an LCD screen. When the file approaches the apex, the device triggers an audible alarm and displays 'apex' on the screen. This real-time feedback assists clinicians in accurately performing root canal treatments, potentially improving procedural outcomes.

Clinical Evidence

Bench testing only. Performance was validated through comparative accuracy testing against the predicate, electrical safety (IEC 60601-1, IEC 80601-2-60), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, -5, -10), and reprocessing validation. Software verification and validation were performed for a moderate level of concern.

Technological Characteristics

Electronic apex locator; impedance-based sensing of two frequencies. Materials: SUS 304 (stainless steel) conforming to ISO 10993. Power: 3.6Vdc rechargeable Li-ion battery. Display: LCD. Connectivity: Standalone. Sterilization: Autoclave for patient-contact accessories (lip hook, file holders). Standards: IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 62304, ISO 14971, ISO 10993 series.

Indications for Use

Indicated for measuring the working length of root canals in patients undergoing root canal procedures.

Predicate Devices

• I-ROOT 100 (K112508)

Submission Summary (Full Text)

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October 20, 2021

Meta Systems Co., Ltd. Hyejin Park RA Staff #1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229 KOREA

Re: K210789

Trade/Device Name: EQ-PEX Regulatory Class: Unclassified Product Code: LQY Dated: September 13, 2021 Received: September 22, 2021

Dear Hyejin Park:

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 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

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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, 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)

K210789

Device Name EQ-PEX

Indications for Use (Describe)

EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.

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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## 510(K) SUMMARY K210789

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter Information: | Meta Systems Co., Ltd.<br>#1214-18, Sicox tower 12F, 484, Dunchon-daero,<br>Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229,<br>Korea<br>Tel: [phone] |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3007663058 |
| Contact Person: | Hyejin Park |
| Date Summary Prepared: | October 19, 2021 |

Device Information:

| Trade name(s): | EQ-PEX |
|--------------------|--------------------|
| Common/Usual Name: | Locator, Root Apex |
| Classification | Unclassified |
| Panel: | Dental |
| Product Code | LQY |

### Predicate Device Information:

[1] K112508 / I-ROOT 100 / S-Denti Co. Ltd.

#### Device Description:

EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord.

The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.

#### Indications for Use:

EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.

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## Comparison to Predicate Device(s):

| Item | Proposed Device | Predicate Device(s) | Similarities/ Differences |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | EQ-PEX | I-ROOT 100 | - |
| Manufacturer | Meta Systems Co., Ltd. | S-Denti Co. Ltd. | --- |
| Establishment<br>Registration<br>Number | 3007663058 | --- | --- |
| 510(k) number | K210789 | K112508 | --- |
| Product code | LQY | LQY | Identical to predicate devices |
| Classification | Unclassified, Dental | Unclassified, Dental | Identical to predicate devices |
| Principle of<br>operation | The position of the file in<br>the root canal is expressed<br>by the ratio of the<br>impedances of two<br>different frequencies. | The position of the file in<br>the root canal is expressed<br>by the ratio of the<br>impedances of two<br>different frequencies. | Identical to predicate devices |
| Intended Use | EQ-PEX is an Electronic<br>Apex Locator designed for<br>use in measuring the<br>working length of root<br>canals. | i-ROOT 100 is intended for<br>measuringthe length of the<br>root canal for the purpose<br>of performing root canals<br>and related dental<br>procedures. | Similar to predicate devices |
| Usage | Prescription Use | Prescription Use | Identical to predicate devices |
| | Technical Specification | | |
| Power | Internally Powered<br>equipment<br>Rechargeable Lithium ion<br>Battery (3.6Vdc) | 1.5V AA x 3 | The battery power of the<br>EQ-PEX and I-ROOT 100 has<br>different. However, EQ-PEX<br>achieves its intended use based<br>on the same technology and<br>principles of operation as the<br>predicate device I-ROOT 100. |
| Display | LCD | LCD | Identical to predicate devices |
| Accuracy of Apex | <±0.5mm | <±0.5mm | Identical to predicate devices |
| Size | W 90 mm x D 75.4 mm x H<br>73.6 mm | W 110 mm x D 100 mm x H<br>117 mm | The exterior design of EQ-PEX<br>and I-ROOT 100 is different.<br>However, the structure of<br>connecting the probe cord to the<br>main body and displaying the<br>measuring value on the display<br>are the same. |
| Component | EQ-PEX body<br>Probe cord 1EA,<br>Lip hook 5EA,<br>File holder gender 1EA,<br>File holder A 1EA,<br>File holder B 2EA,<br>AC/DC adapter 1EA,<br>Power cord 1EA | Main Body,<br>Probe cord 1EA,<br>Lip holder 5EA,<br>File holder A 1EA,<br>File holder B 2EA | Similarity |
| Mode of operations | Continuous operation | Continuous operation | Identical to predicate devices |
| Sterility | Autoclave Sterilization<br>(Lip hook, File holder A,<br>File holder B) | Autoclave Sterilization<br>(Lip holder, File holder A,<br>File holder B) | Identical to predicate devices |
| | Applied Standards | | |
| Standards met | IEC 60601-1<br>IEC 60601-1-2<br>IEC 80601-2-60<br>IEC 60601-1-6<br>ISO 14971<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 11737-1<br>ISO 11737-2<br>ISO 17665-1<br>ISO 7405<br>IEC 62304 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 80601-2-60<br>IEC 60601-1-6<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 11737-1<br>ISO 11737-2<br>ISO 17664 | Similar to predicate devices |
| Materials | SUS 304<br>Used materials conform to<br>ISO 10993. | SUS 304<br>Used materials conform to<br>ISO 10993. | Identical to predicate devices |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Identical to predicate devices |
| Compatibility with<br>environment and<br>other devices. | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Identical to predicate devices |
| Electrical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Identical to predicate devices |
| Mechanical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Identical to predicate devices |
| Radiation safety | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Identical to predicate devices |
| Thermal safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Identical to predicate devices |

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## Summary of the technological characteristics compared to the predicate device

New device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table as attached.

### Performance Testing (Non-Clinical Study)

To be in compliance with electromagnetic safety and compatibility, appropriate study has been applied to the new device in accordance with the following standards.

- EN ISO 14971:2012
- IEC 60601-1:2005 + A1:2012
- EN 60601-1-2:2014
- IEC 80601-2-60:2019
- IEC 60601-1-6:2010/AMD1:2013
- EN ISO 10993-1:2009
- EN ISO 10993-5:2009
- EN ISO 10993-10:2013
- ISO 7405:2018
- IEC 62304:2006 + AMD1:2015

To demonstrate the performance of the EQ-PEX and to demonstrate substantial equivalence to the predicate, the following non-clinical testing was performed:

- Biocompatibility evaluation per ISO 10993-1 assessed the risk for biocompatibility testing for cytotoxicity. ● sensitization and irritation to ISO 10993-5, 10
- Electrical safety testing per IEC 60601-1 and IEC 80601-2-60 ●
- Electromagnetic Compatibility testing per IEC 60601-1-2 ●
- Reprocessing validation (cleaning and sterilization) per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- Software verification and validation testing has been completed for a Moderate Level of Concern software ● and software documentation per FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Comparative performance testing of the accuracy of the apex locator and usability validation.

#### Conclusion

As stated above, the new device has the same device characteristics as the predicate device. The information provided in this summary concludes that the new device is substantially to the i-ROOT 100.