The LED Curing Light is used for light curing polymerization of dental composites, luting materials, cements and other light cured materials. The device is a cordless pen style, LED light polymerization device for use by dental professionals in dental offices or dental laboratories.

The LED Curing Light protect the handpiece from gross contamination and prevent cross infection between patients by applying the single use protective sleeve. The protective sleeve (patient contact part) is made of PP material.

DB686 NANO:
The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key.

The LED Curing Light DB686 NANO has one mode namely: Curing light mode.

DB686 SWIFT:
The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display.

The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "LED Curing Light" (models DB686 NANO and DB686 SWIFT). It aims to demonstrate substantial equivalence to a predicate device (D-Lux+) and a reference device (Bluephase Style 20i) rather than presenting a study where the device meets specific acceptance criteria in a clinical or performance assessment.

Therefore, much of the requested information (acceptance criteria table, sample size, ground truth, expert qualifications, MRMC study, standalone performance) is not available in this document. The document focuses on regulatory compliance and comparison to existing devices.

Here's an attempt to extract the relevant information based on the prompt's structure:

1. A table of acceptance criteria and the reported device performance

This document does not present a table of acceptance criteria and reported device performance in the typical sense of a clinical study or a specific performance benchmark for the device itself. Instead, it demonstrates compliance with recognized medical device standards and outlines the specifications of the proposed device compared to predicate devices to establish substantial equivalence.

The "acceptance criteria" here are essentially the standards the device was tested against to confirm its safety and effectiveness, inferred from the non-clinical tests. The "reported device performance" is given in terms of features and conformity to these standards.

Acceptance Criteria (Inferred from Standards & Equivalence)	Reported Device Performance (LED Curing Light)
Biological Safety:
ISO 10993-5:2009 (Cytotoxicity)	Complies
ISO 10993-10:2010 (Irritation & Skin Sensitization)	Complies
ISO 10993-11:2017 (Systemic Toxicity)	Complies
Disposable Protective Sleeves (ISO 10993-5, -10, -11)	Complies
Electrical Safety & Performance:
IEC 60601-1:2012 (Basic Safety & Essential Performance)	Complies
IEC 60601-1-2:2014 (EMC)	Complies
IEC 80601-2-60:2019 (Dental Equipment Specific)	Complies
IEC 62133-2:2017 (Lithium Batteries)	Complies
Optical/Photobiological Safety:
IEC 62471:2006 (Photobiological Safety)	Complies
Wavelength Range: 385 - 515 nm	385 - 515 nm (Same as predicates)
Light Output Intensity (DB686 NANO): 1600 - 1800 mW/cm²	1600 - 1800 mW/cm²
Light Output Intensity (DB686 SWIFT): 1600 - 1800 mW/cm²	1600 - 1800 mW/cm² (Comparable to Ref. 2000 mW/cm²)
Protection against blue light hazards	Achieved via Cure Tip, protective sleeves, and/or protective glasses
Intended Use:
Polymerization of dental composites, luting materials, cements, and other light-cured materials	Matches predicate and reference devices
Sterility:	Non-sterile (Same as predicates)
Infection Control:	Use disposable Protective Sleeve and surface disinfection
Power Supply:	Adapter: 100-240V, 50-60Hz; Output: 5V 1.5A

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical data or performance data with a specific sample size. The tests conducted are non-clinical, related to compliance with standards (e.g., biological evaluation, electrical safety). The nature of these tests does not typically involve sample sizes in the same way clinical studies do. The data provenance is implied by the testing against international standards, but specific country of origin or retrospective/prospective nature isn't stated for the non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document refers to non-clinical tests and demonstrations of compliance with standards, not a study involving expert-established ground truth for a test set of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.

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 device is an "LED Curing Light," which is a physical device used for polymerization, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not applicable. The device is a physical LED curing light and does not involve an algorithm working in "standalone" mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For the non-clinical tests, "ground truth" would be defined by the technical specifications of the device and the requirements of the standards themselves (e.g., a certain current tolerance for electrical safety, or lack of cytotoxic effect in a cell culture test). There is no "expert consensus" or "pathology" in the context of this device's non-clinical testing.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/machine learning model, so there is no training set.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

December 8, 2022

Foshan COXO Medical Instrument Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K220826

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: September 9, 2022 Received: September 9, 2022

Dear Ray Wang:

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

{1}------------------------------------------------

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,

Bobak Shirmohammadi -S

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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K220826

Device Name

LED Curing Light

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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}------------------------------------------------

The assigned 510(k) Number:

Tab #6 510(k) Summary

This 510(k) Summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation:2022/11/22
1. Sponsor Identification

Foshan COXO Medical Instrument Co., Ltd.

BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226 Guangdong, China.

Contact Person: Yongjian Zheng Position: Legal Representative Tel: +86-13702544788 Fax: +86-757-81800058 Email: 13702544788@163.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

{4}------------------------------------------------

4. Identification of Proposed Device

Trade Name: LED Curing Light Common Name: Ultraviolet activator for polymerization

Regulatory Information Classification Name: Ultraviolet activator for polymerization Classification: II Product Code: EBZ Regulation Number: 21 CFR 872.6070 Review Panel: Dental

Indication for use Statement:

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

Device Description:

DB686 NANO:

The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key.

The LED Curing Light DB686 NANO has one mode namely: Curing light mode.

DB686 SWIFT:

The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display.

The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.

{5}------------------------------------------------

న్. Identification of Predicate Device(s)
Primary Predicate Device 510(k) Number: K200809 Product Name: D-Lux+ Manufacturer: DiaDent Group International

Reference Device: 510(k) Number: K163613 Product Name: Bluephase Style 20i Manufacturer: Ivoclar Vivadent, AG

Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
IEC 62471:2006 Photobiological safety of lamps and lamp systems
A IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
Clinical Test Conclusion 7.

No clinical study is included in this submission.

{6}------------------------------------------------

Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device		Predicate Device	Reference Device	Remark
Device name	LED Curing Light		K200809	K163613	/
	DB686 NANO	DB686 SWIFT	D-Lux+	Bluephase Style 20i	/
Device model			D-Lux+	Bluephase Style 20i	/
ClassificationRegulation	21 CFR 872.6070		21 CFR 872.6070	21 CFR 872.6070	SAME
Classification	II		II	II	SAME
Product Code	EBZ		EBZ	EBZ	SAME
CommonName	Ultraviolet activator for polymerization		Ultraviolet activator forpolymerization	Ultraviolet activator forpolymerization	SAME
Indicationsfor use	For light curing polymerization of dentalcomposites, luting materials, cements andother light cured materials.		The D-Lux+ isintended to polymerizeresinous dentalmaterials, restorativecomposite materials,and orthodonticbrackets, bonding andsealing materials thatare photo-polymerizedin the 385~515nmwaveband of visiblelight.	With its "Polywave"broadband spectrum,Bluephase Style 20i issuitable for thepolymerization of alllight curing dentalmaterials curing in thewavelength range of385 – 515 nm. Thesematerials includerestoratives, bondingagents/adhesives, bases,liners, fissure sealants,temporaries, as well asluting materials forbrackets and indirectrestorations, such asceramic inlays.	EquivalentThe proposeddevices,ReferenceDevice and thepredicate deviceare all indicatedto thepolymerizationof all light curingdental materialscuring in thewavelengthrange of 385 -515 nm.
Principles ofoperation	1. Clean anddisinfect all thesurfaces ofhandpiece and tipbefore each use.2. Cover the CureTip and handpiecewith the DisposableProtective Sleeve.4. Operate therotary switch toCure. Press the	1. Clean anddisinfect all thesurfaces ofhandpiece and tipbefore each use.2. Cover the CureTip and handpiecewith the DisposableProtective Sleeve.3. Select curingmode and curetimes/ orthodontic	1.Disinfectcontaminated surfacesof the curing light aswell as light guides andanti-glare cones beforeeach use.2.Make sure that thestipulated lightirradiance permitsadequatepolymerization. Forthat purpose, check the	1. Disinfectcontaminated surfacesof the curing light aswell as light probes andanti-glare cones beforeeach use.2. Make sure that thestipulated light intensitypermits adequatepolymerization. For thatpurpose, check the lightprobe for contamination	DifferentAnalysis (1)

	Start key to activatelight. Press once orDouble press toselect curing time .5. Once the selectedcuring time haselapsed, the curingprogram isautomaticallyterminated.	cycle(s) .4. Short pressPower/Start Buttonto start working.Once the selectedcuring time haselapsed, the curingprogram isautomaticallyterminated.	light probe forcontamination anddamage, as well as thelight irradiance atregular intervals.3.Select curingprogram and time.4.Start: Once theselected curing timehas elapsed, the curingprogram isautomaticallyterminated.	and damage, as well asthe light intensity atregular intervals.3. Select curingprogram and time4. Start: Once theselected curing time haselapsed, the curingprogram isautomaticallyterminated.
Deliveryform content	-Handpiece-Charging Base-Cure Tip-Protection glasses-Battery pack-Adapter (withPower Cord)-Protective Sleeve-User Manual	-Handpiece-Charging Base-Cure Tip-Battery (Includedin the handpiece)-Adapter (withPower Cord)-Protective Sleeve-User Manual	terminated.-D-Lux+ Handpiece-D-Lux+ Charger-Light Probe-Light Protector-C-Battery (Included inthe handpiece)-Adapter-Power Cord-Disposable Sheaths(200ea/Box)-User Manual	- Charging base withpower cord andpower pack- Handpiece- Light probe-Anti-glare shield-Anti-glare cones-Pack of sleeves- Instructions for use	DifferentAnalysis (2)
Wavelengthrange	385 - 515 nm		385 – 515 nm	385 - 515 nm	SAME
Use	Prescription / Hospital		Prescription / Hospital	Prescription / Hospital	SAME
Operationalmodes	1 programs:Curing lightMode:10s, 20s(1600 ~ 1800mW/cm²)	3 programs:- Soft up mode: 5s,10s, 15s, 20s (1600mW/cm²)- High power mode:5s (1700 mW/cm²)- Orthodonticmode:(1800 mW/cm²)		High 1,200 mW/cm²(10, 15, or 20 sec)Turbo 2,000 mW/cm² (5Sec)	DifferentAnalysis (3)
Power Supply	Adapter:100V - 240V- 50 - 60 HzOutput: 5V 1.5ABatterycharging		100-240VAC, 50-60Hz,Output: 6VDC/2AWirelessly Batterycharging		DifferentAnalysis (4)
Sterility	Non-sterile		Non-sterile	Non-sterile	SAME
Electrical	IEC 60601-1		IEC 60601-1	IEC 60601-1	SAME
Safety	IEC 60601-1- 2	IEC 60601-1- 2	IEC 60601-1- 2
Photobiological safety	IEC 62471	IEC 62471	/	SAME
Biocompatibility	Direct contact with issue in not intended.Therefore ISO10993-1 is not applicable.	Direct contact with issue in not intended.Therefore ISO10993-1 is not applicable.	/	SAME
InfectionControl	Use disposable Protective Sleeve and surface disinfection to prevent cross infection of the Patient .	Use disposable sheath and surface disinfection to prevent cross infection of the patient.	The curing light also is sold with plastic sleeves for infection control.	EquivalentAnalysis (5)

Table 1 General Comparison

{7}------------------------------------------------

{8}------------------------------------------------

Analysis:

Analysis (1):

Although the device design and operational mode between the proposed devices and the predicate device are minor different, they are both complied with IEC60601-1, IEC 60601-1-2 and IEC 62471. The performance of proposed devices complies with IEC80601-2-60. The differences do not affect the safety and effectiveness.

Analysis (2):

The proposed devices use a Cure Tip, the predicate device uses a light guide; the proposed devices provide Protection glasses or recommend wearing Protection glasses for patients, the predicate device provide Light Protector. However, they all can block the blue light radiation outside the application part to protect the operator's eyes from blue light hazards. The performance of proposed devices complies with IEC 62471. The differences do not affect the safety and effectiveness.

Analysis (3):

The light output intensity of the proposed devices (1800 mW/cm² ) is comparable to the Reference Device (2,000 mW/cm²) .The proposed 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, IEC60601-1- 2 and FDA guidance performance testing requirements. The testing results show that these difference do not affect the safety and effectiveness .

Analysis (4):

The proposed device is charged by the charging method by the contact. However, the predicate device is wirelessly charged without a contact using a wireless charger. As a power source for the charger, the AC/DC adapter provided by the manufacturer is used. The input specifications of the adapter (100-240VAC, 50-60Hz) are the same, but the outputs differ from each other at 5V 1.5A and 6VDC/2A respectively. These difference do not the affect safety and effectiveness.

Analysis (5):

Both the proposed device and predicate device use disposable Protective Sleeve and surface disinfection to prevent cross infection of the patient, and the Disposable Protective Sleeves are complied with ISO 10993-5 , ISO 10993-10 and ISO 10993-11. The proposed device is substantially equivalent to the predicate device.

{9}------------------------------------------------

Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) 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.