Who is the manufacturer of EQ-M?

Meta Systems Co., Ltd. filed the 510(k) submission for EQ-M (K210475).

What is the FDA product code for EQ-M?

EKX. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for EQ-M?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EQ-M?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EQ-M

K210475 · Meta Systems Co., Ltd. · EKX · Sep 21, 2022 · Dental

Device Facts

Record ID	K210475
Device Name	EQ-M
Applicant	Meta Systems Co., Ltd.
Product Code	EKX · Dental
Decision Date	Sep 21, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.

Device Story

EQ-M is a battery-powered dental micro-motor handpiece; used for root canal enlargement and gutta-percha removal. Rotational power is generated by a micro-motor and transmitted via bevel gear and shaft to a dental file. When connected to the EQ-PEX Apex Locator, the device tracks file tip position within the root canal using impedance measurements at two frequencies. The system displays canal length data as numbers and graphs on a screen. Used in dental clinics by practitioners; provides real-time feedback via visual display and audible alarms when the file approaches the apex. Benefits include precise canal preparation and monitoring of file depth to prevent over-instrumentation.

Clinical Evidence

Bench testing only. Compliance with electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993), and performance standards (ISO 14457, IEC 80601-2-60) was demonstrated. No clinical data provided.

Technological Characteristics

Battery-powered (Li-ion 3.7V) micro-motor handpiece. Materials conform to ISO 10993. Features include contra-angle head, bevel gear transmission, and impedance-based apex location. Connectivity via probe cord to EQ-PEX. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, ISO 10993, ISO 14457, IEC 80601-2-60.

Indications for Use

Indicated for dental patients requiring root canal enlargement, preparation, gutta-percha removal, and root canal length measurement when used with the EQ-PEX Apex locator.

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 mini (K112665)

Reference Devices

Tri Auto ZX2 (K170275)

Related Devices

K222548 — Endo Motor · Shenzhen Perfect Medical Instruments Co., Ltd. · Apr 26, 2023
K201993 — E-connect S Endo Motor with built-in Apex Locator · Changzhou Sifary Medical Technology Co., Ltd. · Jan 29, 2021
K191276 — Dental Electrical Motor iRoot Pro · Changzhou Bomedent Medical Technology Co.,Ltd · Jun 30, 2020
K112665 — TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE · J. Morita USA, Inc. · May 4, 2012
K170275 — Tri Auto ZX2 · J. Morita USA, Inc. · Sep 11, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 21, 2022 Meta Systems Co., Ltd % Yang Ho Dong Manager Onbix Corporation #821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu Seoul, 06253 SOUTH KOREA Re: K210475 Trade/Device Name: EQ-M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX, LQY Dated: August 16, 2022 Received: August 23, 2022 Dear Yang Ho Dong: 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. {1}------------------------------------------------ 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210475 Device Name EQ-M Indications for Use (Describe) The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY K210475 This 510(k) summary is being submitted in accordance with the requirements of 21 CFR ઠુક્ષ્ઠ07.92. | 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 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ho Dong, Yang Onbix Corporation #821 Samil Plaza, 14 Dogokro 1-gil Gangnam-gu, Seoul, Korea (06253) Tel: *82-2-566-3360 / Fax: *82-2-6280-3360 Email: onbix@naver.com | | Date Summary Prepared: | Sep 16, 2022 | | Device Information: | | | Trade Name(s): | EQ-M | | Common/Usual Name: | Dental Endo Motor | | Classification Name: | handpiece, direct drive, ac-powered | | Regulation Class: | Class 1 | | Panel: | Dental | | Regulation Number: | 872.4200 | | Primary Product Code: | FKX | #### Predicate Device Information: Additional Product Code: | | K number | Device name | Manufacturer | |-----------------------------|----------|---------------|------------------------| | Primary Predicate Device | K112665 | Tri Auto mini | J. MORITA MFG. CORP | | Reference Device | K170275 | Tri Auto ZX2 | J. MORITA MFG. CORP | LQY #### Device Description: EQ-M is micro motor needed to make canal enlargement for root canal treatment. The battery in the motor handpiece is used as a power source and the rotational power generated by rotating the micro motor is transmitted to the crown gear of the angle head through the bevel gear and shaft. The resulting rotational power is transmitted to the file to rotate the file. When connected to Apex Locator (EQ-PEX), the EQ-M indicates the position of the file tip inside the root canal. The EQ-PEX is Electronic Apex Locator and accessories to be used to treat patients. It consists of the main body and lip hook, probe cord. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. 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. {4}------------------------------------------------ #### Indications for Use: The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove guttapercha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals. # Comparison to Predicate Device(s): This device is equivalent to the predicate devices in its intended use and technological characteristics, including: - * indications for use - * technological characteristics - * performance properties # Summary of the technological characteristics compared to the predicate device Subject device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table as attached. #### Comparison of Technical characteristics | Features | Subject Device | Primary Predicate Device | Reference Device | Comparison | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--| | Product name | EQ-M | Tri Auto mini | Tri Auto ZX2 | - | | | 510(k) number | - | K112665 | K170275 | - | | | Applicant | Meta Systems Co., Ltd. | J. MORITA MFG. CORP. | J. MORITA MFG. CORP. | - | | | Primary Product Code | EKX | EKX | EKX | Same. | | | Additional Product Code | LQY | - | LQY | Same | | | Components | Handpiece, Contra angle, Battery, Battery charger, Power Cord, AC/DC Adapter | Handpiece, Contra angle, Battery, Battery charger, Power Supply Cord | Handpiece, Contra angle, Battery Charger, AC Adapter, Contrary Electrode, File Holder, Probe Cord | Same | | | Operation with Apex Locator | 1. Connect Contra angle 2. File installation 3. Connect the handpiece to the Apex Locator with a Transmission cable (probe cord). 4. The measurement bar shows the location of the file tip. 5. Hook the Contrary Electrode (Lip hook) in the corner of the patient's mouth. 6. Operate the handpiece. 7. If the file tip goes past the Flash bar, | 1. Connect Contra angle 2. File installation 3. Connect the handpiece to the Apex Locator with a Transmission cable. 4. The measurement bar shows the location of the file tip. 5. Hook the Contrary Electrode in the corner of the patient's mouth. 6. Operate the handpiece. 7. If the file tip goes past the Flash bar, an alarm will sound | 1. Connect Contra angle 2. File installation 3. Connect the probe cord to the motor handpiece. 4. Connect the file holder and the lip hook to the probe cord respectively. 5. The measurement bar shows the location of the file tip. 6. Hook the Contrary Electrode in the corner of the patient's mouth. 7. Operate the handpiece. 8. If the file tip goes | Same | | | | an alarm will sound and the backlight will blink on an off. | and the backlight will blink on an off. | past the Flash bar, an alarm will sound and the backlight will blink on an off. | | | | Comparison Statement | The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator, the EQ-M can be used to measure the length of root canals. | The Tri Auto mini motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning. When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals. | The Tri Auto ZX2 device is a cordless endodontic treatment motorized handpiece with root canal measurement 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. | Same | | | Principle of operation | The battery in the motor handpiece is used as a power source and the rotational power generated by rotating the micro motor is transmitted to the crown gear of the angle head through the bevel gear and shaft. The resulting rotational power is transmitted to the file (tip) to rotate the file (tip). When connected to Apex Locator (EQ-PEX), the EQ-M indicates the position of the file tip inside the root canal. | The Tri Auto mini is a Battery- driven handpiece with a motor, equipped with the chuck for holding rotary instrument such as a dental file and a reamer. Tri Auto mini can be used for enlargement and preparation of root canals. When connected to Apex Locator, the Tri Auto mini indicates the position of the file tip inside the root canal. | Electrical motor drives the rotating of file equipped on the rotating to accomplish its indication for use. And the software control the parameter and method of rotating. | Same | | | Intended use | - Canal enlargement - Root canal length measurement (When connected to Apex Locator) | - Canal enlargement - Root canal length measurement (When connected to Apex Locator) | - Canal enlargement - Root canal length measurement | Same | | | Indication for use | The EQ-M motorized | The Tri Auto mini motorized | The Tri Auto ZX2 device is a cordless | Same | | | handpiece can be used to enlarge and prepare root canals, remove gutta- percha points. When connected to Apex locator (EQ- PEX), the EQ-M can be used to measure the length of root canals. | handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning. When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals. | endodontic treatment motorized handpiece with root canal measurement 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. | | | | | Device Description | EQ-M is micro motor needed to make canal enlargement for root canal treatment. The battery in the motor handpiece is used as a power source and the rotational power generated by rotating the micro motor is transmitted to the crown gear of the angle head through the bevel gear and shaft. The resulting rotational power is transmitted to the file to rotate the file. When connected to Apex Locator (EQ- PEX), the EQ-M indicates the position of the file tip inside the root canal. The EQ-PEX is Electronic Apex Locator and accessories to be used to treat patients. It consists of the main body and lip hook, probe | The Tri Auto mini is a battery- driven handpiece with a motor, equipped with the chuck for holding rotary instrument such as a dental file and a reamer. Tri Auto mini can be used for enlargement and preparation of root canals. When connected to Apex Locator (Which is not included in this application), the Tri Auto mini indicates the position of the file tip inside the root canal. | The Tri Auto ZX2 is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file and reamer. The Tri Auto ZX2 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 the situation by switching (reversing) the rotation direction. Rotation speed is accelerated or decelerated according to the user's preference, rotation control based on torque detection, or set timing. These controls enable the | Same | | | | cord. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. 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 an alarm will beep and the text apex will appear on the measurement screen. | | cutting, grinding, enlargement, and preparation of root canals. Moreover, the Tri Auto ZX2 can be used for the removal of extraneous materials such as gutta- percha points, and for professional mechanical tooth cleaning. In addition, the Tri Auto ZX2 can be used as an apex locator, and the measured value can be used for rotation control. | | | | Usage | Prescription Use | Prescription Use | Prescription Use | Same | | | | | Technical Specification | | | | | Energy used and/or delivered | Li-ion battery (DC 3.7V) | Li-ion battery (DC 3.7V) | Li-ion battery (DC 3.7V) | Same | | | Exterior Design | 28 mm x 27.2 mm x 154.4mm Charger: 80 mm x 83 mm x 89.5 mm | 18 mm x 18 mm x 165 mm Charger: 85 mm x 108 mm x 68 mm | 30 mm x 30mm x 200 mm Charger: 85 mm x 85mm x 75 mm | Different (1) | | | Performance 1 - canal enlargement | 100-1,000rpm, 4Ncm | 50-1,000rpm, 4Ncm | 100-1,000rpm, 4Ncm | Same | | | Performance 2 - apex locator | Accuracy of the root apex locator function: -0.5mm to +0.5mm from Apex position | - | Accuracy of the root apex locator function : - 1.5mm to +0.5mm for Apex position. | Different (2) | | | Setting Mode | EAL: When the Apex Locator and EQ-M are connected properly. CW: The motor rotates clockwise. CCW: The motor rotates counterclockwise. RCP: The motor alternates between clockwise and counterclockwise rotation. ART: The motor rotates clockwise while changing its speed. | Linked function: These functions are available only when connected to the Electronic Apex Locator. Fwd: The motor rotates clockwise. Rev: The motor rotates counterclockwise. Torque Reverse: nine torque reverse settings Auto controls: Auto torque Reverse/ Auto torque slowdown | EMR Mode: This mode is for canal measurement. CW Mode: The motor rotates clockwise. OGP Mode: Optimum Glide Path function is used for canal negotiation and making the glide path. | Different (3) | | | Display setting | 1. Memory number 2. EQ-M and Apex Locator connection 3. Battery Power 4. Motor operation information 1) CW: Rotation Direction 2) RPM: Motor Speed 3) Ncm: Torque 4) STP: The motor stops when it reaches the set torque limit. | 1. Memory number 2. Rotation Direction 3. Battery Power 4. Speed Setting 5. Torque Reverse Setting | 1. Memory Number 2. Battery Power 3. Operation Mode 4. Speed Setting 5. Torque Limit Setting | Same. | | | Spray nozzle | Spray nozzle | - | Spray nozzle | Same | | | Sterility | Contra angle (Lip hook are not attached) | Contra angle (File holder and Contrary electrode are not attached) | File holder, contrary electrode, and contra angle are autoclavable. | Same | | | Applied Standards | | | | | | | Standards met | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 IEC 62304 ISO 14971 ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 17665-1 ISO 17665-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-1-6 ISO 14971 ISO 10993-1 ISO 10993-5 ISO 10993-12 ISO 17664 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 IEC 62304 IEC 62366 ISO 14971 ISO 10993-1 ISO 10993-5 ISO 10993-12 ISO 15223-1 | Different (4) | | | | ISO 11737-1 IEC 62366-1 IEC 62133-2 IEC 80601-2-60 ISO 14457 ISO 1797-1 ISO 7405 ISO 15223-1 | | ISO 17664 | | | | Materials | Materials conform to ISO 10993. | Materials conform to ISO 10993. | Materials conform to ISO 10993. | Same | | | Compatibility with environment and other devices. | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Same | | | Electrical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Conform to IEC 60601-1…

EQ-M

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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EQ-M

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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