The LEDEX WL-120 device using highly efficient LEDs with a thermal management system, while maintaining consistent performance even in the most challenging and demanding curing needs. The light has four LED curing chips with a range of 390 nm, thus effectively curing all composites. About the light guide rod, it is made of genuine optical fiber which can optimize light conduction and minimize loss of light from source to tip. It therefore ensures the most possible intensity of light at the light guide tip. Furthermore, we design advanced efficient cooling heat sink which accompanies with over temperature protection. The thermal protection circuits prevent the light from overheating and help to keep the device in a safety mode. Automatic memorizing the last group of operation is another unique feature of this device.

AI/ML Overview

The provided documentation describes the acceptance criteria and the study that proves the device, LEDEX WL-120, meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Descriptive Information	Acceptance Criteria	Reported Device Performance
FDA-Recognized Standards: Electrical Safety(IEC 60601-1:2005 + A1:2012, ISO 10650:2015)	Pass test and got Verification of Compliance	Test passed, Verification of Compliance obtained.
FDA-Recognized Standards: Electromagnetic Compatibility(IEC 60601-1-2: 2014, ISO 10650:2015)	Pass test and got Verification of Compliance	Test passed, Verification of Compliance obtained.
Irradiation (Optical power testing)	Conformed to requirements of ANSI/ADA Spec. 48-2, 48, and FDA Guidance	Tests conformed to requirements of standards.
Spectral irradiance plot (Wavelength spectrum testing)	Conformed to requirements of ANSI/ADA Spec. 48-2, 48, and FDA Guidance	Tests conformed to requirements of standards.
Depth of cure (Composite hardness testing)	Conformed to requirements of ANSI/ADA Spec. 48-2, 48, and FDA Guidance	Tests conformed to requirements of standards.
Safety and Performance (per IEC 60601-1, ANSI/ADA Spec. No. 42, 42-2, and FDA Guidance)	No problems raised in safety and performance	Differences in operational modes did not raise any safety or performance problems.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set in terms of the number of devices or number of materials tested. It refers to specific standards for performance testing (ANSI/ADA Specification No. 48-2, No. 48, and FDA Guidance). These standards typically define the procedures and potentially the sample sizes for testing medical devices.

The data provenance is implied to be from in-vitro testing conducted by DENTMATE TECHNOLOGY CO., LTD. for regulatory submission, rather than data from human subjects or from a specific country of origin in terms of clinical data. It is a prospective generation of data for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device clearance based on engineering and performance testing against recognized standards, not on expert-adjudicated clinical or imaging data. The "ground truth" is defined by the technical specifications and performance limits set by the referenced standards (ANSI/ADA, IEC, and FDA guidance documents).

4. Adjudication method for the test set

Not applicable. The tests performed are objective measurements against established technical specifications and performance requirements defined in the cited standards, not subjective assessments requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The LEDEX WL-120 is a dental curing light, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The LEDEX WL-120 is a physical medical device (dental curing light), not an algorithm or software. It is designed to be used by dental professionals (human-in-the-loop operates the device). The performance tests are for the device's physical output and effect on dental materials, not for an algorithm's standalone performance.

7. The type of ground truth used

The "ground truth" for the performance of the LEDEX WL-120 is based on established technical specifications and performance requirements outlined in recognized national and international standards. These include:

American National Standard/American Dental Association (ANSI/ADA) Specification No. 48-2: 2010, Reaffirmed 2015, LED Curing Lights
American National Standard/American Dental Association (ANSI/ADA) Specification No. 48: 2020, Approved 2020, Curing Lights (Powered Polymerization Activators)
FDA Guidance for Industry and FDA Staff, Dental Curing Lights - Premarket Notification 510(k) Submissions, Clause 8. Performance Specifications
IEC 60601-1 (Electrical safety)
IEC 60601-1-2 (Electromagnetic compatibility)
ISO 10650:2015 (Dentistry - Powered polymerization activators)

These standards define acceptable ranges for parameters like irradiation, spectral irradiance, and depth of cure, as well as safety criteria.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance evaluation is based on testing a physical device against specified criteria.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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September 16, 2022

Dentmate Technology Co. Ltd. Cheng-Feng Chou President 8F, No.8-11, Sec. 1, Zhongxing Road, Wugu District. New Taipei, 24872 Taiwan

Re: K221194

Trade/Device Name: LEDEX WL-120 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: July 11, 2022 Received: July 18, 2022

Dear Cheng-Feng Chou:

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

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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 (OS) 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,

For 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) K221194

Device Name LEDEX WL-120

Indications for Use (Describe)

LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

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)

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K221194

510(k) Summary

Date: 04/21/2022

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

1. Applicant/Submitter

DENTMATE TECHNOLOGY CO., LTD. Registration Number: 3007662989 Address: 8F, No. 8-11, Sec. 1, Zhongxing Road, Wugu District, New Taipei City, 24872 Taiwan TEL: +886 2 8976 9226 Fax: +886 2 8976 9236 Email: info@dentmate.com.tw

2. Official/Submission correspondent

Mr. Cheng-Feng Chou Address: 8F, No. 8-11, Sec. 1, Zhongxing Road, Wugu District, New Taipei City, 24872 Taiwan TEL: +886 2 8976 9226 Fax: +886 2 8976 9236 Email: info@dentmate.com.tw

3. Device Information

Common Name: LED Dental Curing Light Device Trade Name: LEDEX Model Number: WL-120 Classification name: Ultraviolet Activator for Polymerization Device class: II Panel: Dental Product Code: EBZ Regulation Number: 872.6070

Indications for use ব

LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

5. Predicate device

LEDEX WL-090/WL-090+, (K)131042 by DENTMATE TECHNOLOGY CO., LTD.,

6. Description of device

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About the light guide rod, it is made of genuine optical fiber which can optimize light conduction and minimize loss of light from source to tip. It therefore ensures the most possible intensity of light at the light guide tip.

Furthermore, we design advanced efficient cooling heat sink which accompanies with over temperature protection. The thermal protection circuits prevent the light from overheating and help to keep the device in a safety mode. Automatic memorizing the last group of operation is another unique feature of this device.

7. Substantial Equivalence

LEDEX WL-120 is substantially equivalent to the predicate devices LEDEX WL-090+ (K)131042 by DENTMATE TECHNOLOGY CO., LTD. in terms of intended use, technology and principle of operation.

The following comparison table is presented to demonstrate substantial equivalence.

DescriptiveInformation	Subject Device	Predicate device
Trade name andmodel number	LEDEX WL-120	LEDEX WL-090/WL-090+
Manufacturer	DENTMATE TECHNOLOGY CO.,LTD.	DENTMATE TECHNOLOGY CO.,LTD.
510(k) number	--	K131042
Product Code	EBZ	EBZ
RegulatoryClass	II	II
Indications for use	LEDEX WL-120 is a visible curing unitprogrammed for polymerization ofdental light cured materials by dentalprofessionals.	LEDEX (Family model: WL-090,WL-090+) is a visible curing unitprogrammed for polymerization ofdental light cured materials by dentalprofessionals.
Device Design –Operational modes	Low, Ramp, Standard, High, Turbo,Plasma, White	Low, Ramp, Standard, High, FastOrtho, Turbo, Plasma

Device Design -Light source	10W LED	10W LED
Device Design -Power source	3.7V Rechargeable Li-ion battery	3.7V Rechargeable Li-ion battery
Device Design -Power supply	Input: AC100~240V, 50/60HzOutput: DC 5V/2A	Input: AC100~240V, 50/60HzOutput: DC 5V/2A
Device Design -Accessories	Handpiece, Power supply, Opticalfiber light guide rod, Filter, Light guidesleeves, Cradle, Anti-glare shield	Handpiece, Power supply, Opticalfiber light guide rod, Filter, Light guidesleeves, Cradle, Anti-glare shield
Composition ofMaterials -outer casing	ABS plastic material	ABS plastic material
TechnicalSpecifications -Light intensity	MAX. 3200 mW/cm²	MAX. 3200 mW/cm²
TechnicalSpecifications -Peak wavelength	405 & 460 nm	405 & 460 nm
FDA-RecognizedStandards -Electrical safety	IEC 60601-1:2005 (Third Edition) +CORR. 1:2006 + CORR. 2:2007+ A1:2012 (or IEC 60601-1: 2012reprint)ISO 10650:2015 Dentistry - Poweredpolymerization activators	IEC 60601-1:1988, Medical ElectricalEquipment - Part 1: GeneralRequirements for Safety; includingAmendment 1(1991) and Amendment2(1995).
FDA-RecognizedStandards -Electromagneticcompatibility	IEC 60601-1-2: 2014, Medicalelectrical equipment - Part 1-2:General requirements for basic safetyand essential performance - CollateralStandard: Electromagneticdisturbances - Requirements and testsISO 10650:2015 Dentistry - Poweredpolymerization activators	IEC 60601-1-2, (Second Edition,2001), Medical electrical equipment -Part 1-2: General requirements forsafety; Electromagnetic Compatibility -Requirements and tests.

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7.1 The same between subject device and predicate device:

a) Product Code, Regulatory Class and Manufacturer
b) Indications for use
c) Light source, Power supply and Accessories
d) Outer casing material
e) Light intensity and Peak wavelength

7.2 The different between subject device and predicate device:

a) Operational modes
The subject devices have several modes corresponding to the light output intensity and available times. The light output safety and performance test was conducted according to IEC 60601-1, ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2 and FDA guidance performance testing requirements with the difference. The testing results show that these differences do not raise any problems in the safety and performance.
b) FDA-Recognized Standards Electrical safety & Electromagnetic compatibility
The subject devices accord to new version of Electrical safety & Electromagnetic compatibility Standard; the predicate device was made in 2013, it accorded to old version of Electrical safety & Electromagnetic compatibility Standard.

8. Identification of the risk analysis method

The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA). The design verification tests that were performed as a result of this risk analysis assessment are listed as below. The test methods used are the same as those submitted in the original submission.

DescriptiveInformation	Test Performed	Acceptance Criteria
FDA-RecognizedStandards:ANSI/ADAStandard No.48-2-2010(R2015)	Ask to Electromagnetic Compatibility test	Pass test and got Verification ofCompliance
	Ask to Electrical Safety test	Pass test and got Verification ofCompliance

9. Performance Testing

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The following tests were conducted to evaluate the functionality, performance and substantial equivalence.

a) Irradiation (Optical power testing)
b) Spectral irradiance plot (Wavelength spectrum testing)
c) Depth of cure (Composite hardness testing)

The tests are in accordance with the following standards:

●American National Standard/American Dental Association (ANSI/ADA) Specification No. 48-2: 2010, Reaffirmed 2015, LED Curing Lights

●American National Standard/American Dental Association (ANSI/ADA) Specification No. 48:

2020, Approved 2020, Curing Lights (Powered Polymerization Activators)

●FDA Guidance for Industry and FDA Staff, Dental Curing Lights -Premarket Notification 510(k) Submissions, Clause 8. Performance Specifications

The test results conformed to the requirements of the standards.

10. Conclusion

Validation and verification tests have been conducted to FDA guidance document Dental Curing Lights =Premarket Notification [510(k)]. In comparing between subject device and predicate device, there are the same product code, regulatory classifications for use, light source, power supply, outer casing material, light intensity and peak wavelength of patient contacting portions.

In summary, the WL-120 LED Dental Curing Light in this submission are, in our opinion, substantially equivalent to the predicate device. Safety and performance testing supports substantial equivalence of the subject device to the predicate devices.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.