LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.

LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.

LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.

The enclosure of main unit was composed of ABS material and Aluminum, and the light quide base (patient contact part) was made from ABS material.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LED Curing Light (Model: VK-018), presented in the requested format.

It's important to note that this document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific clinical acceptance criteria from a standalone study. The performance testing here focuses on technical and safety specifications against recognized standards, rather than direct clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Standard	Reported Device Performance
Performance Testing:
ANSI ADA 48: 2004 Visible light curing unit (FDA recognition number 4-139)	Light output performance evaluated. (Specific values within ANSI ADA 48 are not explicitly stated, but compliance is implied.)
IEC 80601-2-60 Medical Electrical Equipment - Part 2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment, Edition 1.0 2012-02 (FDA recognition number 4-229)	Evaluated for basic safety and essential performance. (Specific values within IEC 80601-2-60 are not explicitly stated, but compliance is implied.)
Electrical Safety & EMC:
ANSI/AAMI 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012 (FDA recognition number 19-4)	Found to comply.
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014 (FDA recognition number 19-8)	Found to comply.
Biocompatibility Testing:
ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity (FDA recognition number 2-245)	Evaluated. ABS plastic (patient contact material) found to comply.
ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization (FDA recognition number 2-174)	Evaluated. ABS plastic (patient contact material) found to comply.
Software Verification & Validation Testing:
FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Software level of concern: "moderate")	Software verification and validation testing conducted, and documentation provided as recommended. (Compliance implied.)
Technical Specifications (Comparison to Predicate):
Light intensity (implied range of predicate: 800-2700mW/cm²)	Subject device: 1000mW/cm²-1800mW/cm² ±10%. Light intensity range is within the effective power range of the predicate device and verified via tests.
Light wavelength (predicate: 430~490nm range)	Subject device: 430nm-490nm.
Peak wavelength (predicate: 460nm)	Subject device: 455nm.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical trials or artificial intelligence evaluation with human data. The testing described is primarily bench testing and compliance testing against recognized standards for the device itself. Therefore, specific sample sizes for human subjects or patient data are not applicable here.

Data Provenance: N/A (bench testing of the device hardware and software).
Retrospective or Prospective: N/A (bench testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission focuses on technical and safety compliance based on recognized standards and bench testing, not on comparison to expert-established ground truth from clinical images or data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-adjudicated test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical data were not required in this submission to support a finding of substantial equivalence." (Page 6). Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a hardware product (LED Curing Light), not a software algorithm that performs diagnostic or assistive functions. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by the recognized international and national standards (e.g., ANSI ADA 48, IEC 60601 series, ISO 10993 series) and the technical specifications of the predicate device. The device's performance against these standards and specifications serves as its ground truth.

8. Sample Size for the Training Set

Not applicable. As this is a hardware medical device and not an AI/Machine Learning algorithm, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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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 and 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.

January 9, 2020

EZGO Group Inc. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Cn

Re: K192009

Trade/Device Name: LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: Class II Product Code: EBZ Dated: October 6, 2019 Received: October 11, 2019

Dear Jet Li:

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 medical devices and radiation-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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192009

Device Name

LED Curing Light , Model: VK-018

Indications for Use (Describe)

For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 872.6070.

1. Submitter Information

Sponsor: EZGO Group Inc.

Address: 8840 Flower Rd 120, Rancho Cucamonga CA 91730 US

Contact Person: Hong Chen

Phone: 626-4045522

E-mail: ezgogroupinc@gmail.com

Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl @foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China

2. Subject Device Information

Type of 510(k) submission:	Traditional
Common Name:	Dental Curing Light Device
Trade Name:	LED Curing Light, Model VK-018
Classification Name:	Ultraviolet activator for polymerization
Review Panel:	Dental
Product Code:	EBZ
Regulation Number:	21 CFR 872.6070
Regulation Class:	2

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3. Predicate Device Information

Sponsor:	DENTALL Co., Ltd.
Common Name:	Ultraviolet Activator for Polymerization
Trade Name:	Delight, Delight ortho, B&Lite S
510(k) number:	K170529
Review Panel:	Dental
Product Code:	EBZ
Regulation Number:	21 CFR 870.1130
Regulation Class:	2

Device Description 4.

The enclosure of main unit was composed of ABS material and Aluminum, and the light quide base (patient contact part) was made from ABS material.

5. IntendedUse/ Indication for Use

For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Test Summary 6.

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LED Curing Light has been evaluated the safety and performance by lab bench testing according to the following standards:

A Performance Testing

The light output Performance of subject device was evaluated for below testing item:

ANSI ADA 48: 2004 Visible light curing unit (FDA recognition number 4-139) 区
风 IEC 80601-2-60 Medical Electrical Equipment - Part 2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment, Edition 1.0 2012-02 (FDA recognition number 4-229)

> Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device, and was found to comply with ANSI/AAMI 60601-1 and IEC 60601-1-2.

Detail standard lists is as below items:

-ANSI/AAMI 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012 (FDA recognition number 19-4)
-IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014 (FDA recognition number 19-8)

A Biocompatibility Testing

The biocompatibility of subject device was evaluated for below items:

ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity (FDA recognition number 2-245 )
ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - । part 10: tests for irritation and skin sensitization (FDA recognition number 2-174)

A Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided asrecommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to be of "moderate" level of concern.

7. Clinical Testing

Clinical data were not required in this submission to support a finding of substantial equivalence.

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Comparison to Predicate Device 8.

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.

ElementsofComparison	Subject Device	Predicate Device	Verdict
Manufacturer	EZGO Group Inc.	DENTALL Co., Ltd. (K170529)	--
Product Name	LED Curing Light	Delight, Delight ortho, B&Lite S	SE Note1
Indicationsfor Use
Indications for Use	For light curing polymerization ofdental composites, luting materials,cements and other light curedmaterials.	For light curing polymerization ofdental composites, luting materials,cements and other light cured materials.	SE
Device Design
Power source	Rechargeable Lithium battery withIEC 62133 Approval	Li-ion battery with IEC 62133Approval	SE
Light source	5W high-power blue light LED	blue light LED	SENote 2
Operational mode	TURBO mode: exposure time (1,3seconds)NORMAL mode: exposure time(5,10,15,25,30 seconds)	Standard: 5,10,15, 20s durationHigh: 3,6,9,12 s durationSoft start: 5, 10, 15s duration	SENote 2
Usability	The Display screen and functionbuttons (ON/OFF, Mode, Time)located on the main unit.	A plastic rotation switch providesvarious modes selection.An ON/OFF button activates andexecutes the selected mode.	SENote 2
Accessories	Curing light shield, Charger,Adapter, and the main unit	Cordless handpiece, Battery packs,Curing light shield	SE
Elements ofComparison	Subject Device	Predicate Device	Verdict

Technical Specifications
Light intensity	1000mW/cm²-1800mW/cm²±10%	800mW/cm²-2700mW/cm²	SENote 3
Light wavelength	430nm-490nm	430~490nm range	SE
Peak wavelength	455 nm	460nm	SE
Material information
Patient Contactmaterial: Lightguide base	ABS plastic(Comply with ISO 10993-5; ISO10993-10)	ABS plastic(Comply with ISO 10993-5; ISO10993-10)	SE
FDA-Recognized Standards
Electrical safety,EMC, BiologicalEvaluation	ANSI/AAMI 60601-1:2005+A12012IEC60601-1-2:2014IEC 80601-2-60:2012ADA No 48:2004ISO 10993-5:2009ISO 10993-10:2010	IEC 60601-1IEC 60601-1-2ADA 48 / ISO 10650ISO 10993-5:2009ISO 10993-10:2010	SE

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Note 1

Although there is little difference for their model name, but its common names are the same. This difference does not affect the safety and effectiveness.

Note 2

Although the device design and operational mode between the predicate device and subject device are minor different, they are both complied with IEC60601-1 and its performance comply with IEC80601-2-60, AND ADA 48. The differences do not affect the safety and effectiveness.

Note 3

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Although the light output intensity specification is mirror different, but the light intensity range of subject device is within the effective power range of predicate device, and the safety and performance of the subject device is verified via tests, and it is complied with IEC 60601-1 and IEC 80601-2-60. The differences do not affect the safety and effectiveness.

9. Conclusion

The subject device LED Curing Light has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent to the predicate device.

10. Summary Prepared Date

09 Jan 2020

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.