The ELEC-LED is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.

Device Description

This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and spinning direction through the motor control circuit inside the controller. Motor speed, motor operating mode, light and spinning direction functions can be set on the display panel. The operating mode of the motor is composed of three modes: HD (Hand control mode), PP (Press pedal mode) and EP (Electric pedal mode).

AI/ML Overview

This document pertains to the 510(k) premarket notification for the "ELEC-LED" dental handpiece control unit. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness or performance in an AI-assisted diagnostic context.

Therefore, none of the requested information regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment can be found in this document.

The document details the device's technical specifications, indications for use, and a comparison to a predicate device ("Optima MX INT"). It also lists performance tests conducted, which are primarily non-clinical bench tests for electrical safety, mechanical standards, and biocompatibility, as well as software documentation following FDA guidance for medical device software.

The performance tests mentioned are as follows:

ISO 3964:2016 Dental Handpieces Coupling dimensions
ISO 7494-1:2011 Dentistry Dental units -Part 1: General requirements and test methods
ISO 14457:2017 Dentistry Handpieces and motors
IEC 60601-1, IEC 62366-1, IEC 60601-1-2: Electrical safety and EMC
IEC80601-2-60:2012: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
IEC 62366: Application of usability engineering to medical devices
ANSI AAMI ST79:2017, ISO 17665-1, and ISO TS 17665-2: Sterilization validation

These tests are standard for dental equipment to ensure safety and function, but they are not clinical studies designed to assess diagnostic accuracy or the impact of AI on human reader performance.

Summary

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February 7, 2022

MICRO-NX Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620

Re: K201191

Trade/Device Name: ELEC-LED Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: November 9, 2021 Received: November 12, 2021

Dear Priscilla Chung:

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

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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.Ch.E. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201191

Device Name ELEC-LED

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

(K201191)

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

Date: February 3, 2022

1. 510K Applicant / Submitter:

MICRO-NX Co., Ltd. 22, Maeyeo-ro 1gil, Dong-gu, 41059 Republic of Korea Tel: +82-53-650-1000 Fax: +82-53-650-1001

2. Submission Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com

2. Subject Device

Proprietary Name -ELEC-LED
Common Name Motor Handpiece Control Unit .
. Classification Name -Dental Handpiece and Accessories
Product Code - EBW
Classification Regulation 21 CFR 872.4200

3. Predicate Device

Optima MX INT by Bien air Dental SA (K042759)

4. Description:

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pedal mode).

5. Indications for Use

Substantial Equivalence Discussion: 6.

The subject device is substantially equivalent to Optima MX INT SI0915/923(K042759). The subject device has the same indications for use and the technological characteristics as the predicate device. It also has the equivalent specifications as the predicate device in almost all parameters. The major difference is that the subject device offers a model without water and air spray hoses, and also a model without LED. However, these differences do not raise a question in substantial equivalence discussion since the user can use water and air spray hoses that are usually provided on a dental chair, and lighting system in the dental office. Since these are optional features, we believe these differences do not raise a concern for substantial equivalence. Based on the comparison and the performance test data, we conclude that the subject device is substantially equivalent to the predicate device.

	Subject Device	Predicate Device	Comparison
510(k) Number	K201191	K042759	-
Device Name	ELEC-LED (EL-B40S, EL-B40L,EL-B40M, EL-B40I)	Optima MX INT	-
Manufacturer	MICRO-NX Co.,Ltd.	Bien air Dental SA
Intended Use	The ELEC-LED isintended for use indentistry forrestoration,prophylaxis andendodonticprocedures. Itprovides control formotorized dentalhandpieces byconvertingpneumatic outputform a dentaltreatment center.	The Optima MX isintended for use indentistry forrestoration,prophylaxis andendodonticprocedures. Itprovides control formotorized dentalhandpieces byconverting pneumaticoutput form a dentaltreatment center.	Equivalent

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Micromotor type	Brushless, internalcoolant air	Brushless, internalcoolant air	Identical
Device components	Control unit withhose and electricalmotor	Control unit withhose and electricalmotor	Identical
Power supply voltage	AC 24V	AC 24V	Identical
Speed on the motor	1,000-40,000 rpm	100- 40,000 rpm	Equivalent
Max. Torque	3Ncm	3Ncm	Identical
Rotation direction	clockwise /counterclockwise	clockwise /counterclockwise	Identical
Spray Air Pressure	2.5bar	2.5bar	Identical
Spray Water Pressure	2bar	2bar	Identical
Irrigation system	1) EL-B40S, EL-B40S, EL-B40I(Irrigation system, motor cooling air)2) EL-B40M (only motor cooling air)	Irrigation and motorCooling air	The EL-B40M typedoes not have waterinjection function,therefore, there isno water and airspray hoses.The user can usewater and air sprayhoses that areusually provided ona dental chair.
Light(Motor LED)	1) Yes (EL-B40S, EL-B40L)2) No (EL-B40I, EL-B40M)	Yes	The subject devicehas both a modelwith an LED and amodel withoutLED; however,since this product isused in a dentaloffice which will belikely to havelighting system, itdoes not pose anyrisk.
Conformance withstandards for shanks	Comply withISO 3964	Comply withISO 3964	Identical
Rotation	Clockwise,Counterclockwise	Clockwise,Counterclockwise	Identical

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7. Performance Tests (Non-clinical)

Non-clinical bench tests were performed as followings:

ISO 3964:2016 Dental Handpieces Coupling dimensions
ISO 7494-1:2011 Dentistry Dental units -Part 1: General requirements and test methods
ISO 14457:2017 Dentistry Handpieces and motors
IEC 60601-1, IEC 62366-1, IEC 60601-1-2: Electrical safety and EMC
IEC80601-2-60:2012: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
IEC 62366: Application of usability engineering to medical devices
ANSI AAMI ST79:2017, ISO 17665-1, and ISO TS 17665-2: Sterilization validation

Software documentation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices was provided . The test results support that the subject device is substantially equivalent to the predicate device.

Cleaning and Sterilization validation for the motor cable was provided per the FDA Guidance Document for Reprocessing of Medical Device.

Biocompatibility testing (cytotoxicity, sensitization, and oral mucosa irritation) for the direct and indirect patient contacting components was provided per the FDA Guidance Document for the Use of ISO 10993-1.

8. Conclusions:

Based on the information provided in this premarket notification, MICRO-NX Co., Ltd. concludes that the ELEC-LED is substantially equivalent to the predicate device as described herein in.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
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.(b)
Classification. Class I.