K Number

Device Name

EQ-PEX

Manufacturer

Meta Systems Co., Ltd.

Date Cleared

2021-10-20

(218 days)

Product Code

LQY

Regulation Number

N/A

Intended Use

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

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K112508

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on impedance-based measurement and standard electrical/software testing, with no mention of AI/ML terms or training/test data.

Therapeutic

No.

The device is an apex locator, which is a diagnostic tool used to measure the working length of root canals, not to treat a disease or condition itself.

Diagnostic

Yes

Explanation: The device is an Electronic Apex Locator and is used to measure the working length of root canals to track the position of the file in the root canal based on impedance. This measurement provides information about the patient's internal structure (root canal length), which is then used to guide treatment.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as the main body, lip hook, probe cord, file holder, AC adapter, and power cord. The performance studies also include testing for electrical safety, electromagnetic compatibility, and reprocessing validation, which are relevant to hardware components. While software verification and validation are mentioned, the device is clearly not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the EQ-PEX device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to measure the working length of root canals in vivo (within the patient's body).
Device Description: The device description clearly outlines its use in tracking the position of a file within the root canal based on impedance measurements taken directly from the patient.
Anatomical Site: The anatomical site is "root canals," which are part of the living patient.
Lack of In Vitro Activity: There is no mention of the device being used to test samples of human origin outside of the body, which is the defining characteristic of an IVD.

IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The EQ-PEX is a device used directly on the patient during a dental procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

LQY

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

root canals

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy of Apex:

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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.
#1214-18, Sicox tower 12F, 484, Dunchon-daero,
Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229,
Korea
Tel: +82-31-731-7377 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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:

Indications for Use:

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

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
Registration
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
operation	The position of the file in
the root canal is expressed
by the ratio of the
impedances of two
different frequencies.	The position of the file in
the root canal is expressed
by the ratio of the
impedances of two
different frequencies.	Identical to predicate devices
Intended Use	EQ-PEX is an Electronic
Apex Locator designed for
use in measuring the
working length of root
canals.	i-ROOT 100 is intended for
measuringthe length of the
root canal for the purpose
of performing root canals
and related dental
procedures.	Similar to predicate devices
Usage	Prescription Use	Prescription Use	Identical to predicate devices
	Technical Specification
Power	Internally Powered
equipment
Rechargeable Lithium ion
Battery (3.6Vdc)	1.5V AA x 3	The battery power of the
EQ-PEX and I-ROOT 100 has
different. However, EQ-PEX
achieves its intended use based
on the same technology and
principles of operation as the
predicate device I-ROOT 100.
Display	LCD	LCD	Identical to predicate devices
Accuracy of Apex