LED Curing Light

K220826 · Foshan Coxo Medical Instrument Co., Ltd. · EBZ · Dec 8, 2022 · Dental

Device Facts

• Record ID: K220826
• Device Name: LED Curing Light
• Applicant: Foshan Coxo Medical Instrument Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Dec 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

LED Curing Light (models DB686 NANO and DB686 SWIFT) is a cordless, pen-style dental device used by dental professionals. It utilizes LED radiation to polymerize light-sensitive dental resins, composites, and cements. The device consists of a handpiece, cure tip, battery pack, charging base, and adapter. Users apply a single-use PP protective sleeve to the handpiece and cure tip to prevent cross-contamination. The NANO model features a rotary switch and single curing mode; the SWIFT model features a button interface, LED display, and three modes (soft up, high power, orthodontic). Operation involves selecting a mode and timer, then activating the light via the start key. The device automatically terminates after the set time. By providing controlled light intensity, it ensures proper material hardening, facilitating restorative and orthodontic procedures.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, -10, -11), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and battery safety (IEC 62133-2).

Technological Characteristics

Cordless pen-style LED curing light. Materials: PP (protective sleeve). Principle: LED-based ray radiation for polymerization. Wavelength: 385-515 nm. Power: Rechargeable battery, AC/DC adapter (100-240V). Connectivity: None. Sterilization: Non-sterile; surface disinfection and single-use sleeves. Standards: ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 62471, IEC 62133-2.

Indications for Use

Indicated for light curing polymerization of dental composites, luting materials, cements, and other light-cured materials in dental offices or laboratories.

Regulatory Classification

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.

Predicate Devices

• D-Lux+ (K200809)

Reference Devices

• Bluephase Style 20i (K163613)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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.

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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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone] Fax: [phone] Email: [e-mail]

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#### 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:

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.

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- 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.

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#### 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 | / |
| Classification<br>Regulation | 21 CFR 872.6070 | | 21 CFR 872.6070 | 21 CFR 872.6070 | SAME |
| Classification | II | | II | II | SAME |
| Product Code | EBZ | | EBZ | EBZ | SAME |
| Common<br>Name | Ultraviolet activator for polymerization | | Ultraviolet activator for<br>polymerization | Ultraviolet activator for<br>polymerization | SAME |
| Indications<br>for use | For light curing polymerization of dental<br>composites, luting materials, cements and<br>other light cured materials. | | The D-Lux+ is<br>intended to polymerize<br>resinous dental<br>materials, restorative<br>composite materials,<br>and orthodontic<br>brackets, bonding and<br>sealing materials that<br>are photo-polymerized<br>in the 385~515nm<br>waveband of visible<br>light. | With its "Polywave"<br>broadband spectrum,<br>Bluephase Style 20i is<br>suitable for the<br>polymerization of all<br>light curing dental<br>materials curing in the<br>wavelength range of<br>385 – 515 nm. These<br>materials include<br>restoratives, bonding<br>agents/adhesives, bases,<br>liners, fissure sealants,<br>temporaries, as well as<br>luting materials for<br>brackets and indirect<br>restorations, such as<br>ceramic inlays. | Equivalent<br>The proposed<br>devices,<br>Reference<br>Device and the<br>predicate device<br>are all indicated<br>to the<br>polymerization<br>of all light curing<br>dental materials<br>curing in the<br>wavelength<br>range of 385 -<br>515 nm. |
| Principles of<br>operation | 1. Clean and<br>disinfect all the<br>surfaces of<br>handpiece and tip<br>before each use.<br>2. Cover the Cure<br>Tip and handpiece<br>with the Disposable<br>Protective Sleeve.<br>4. Operate the<br>rotary switch to<br>Cure. Press the | 1. Clean and<br>disinfect all the<br>surfaces of<br>handpiece and tip<br>before each use.<br>2. Cover the Cure<br>Tip and handpiece<br>with the Disposable<br>Protective Sleeve.<br>3. Select curing<br>mode and cure<br>times/ orthodontic | 1.Disinfect<br>contaminated surfaces<br>of the curing light as<br>well as light guides and<br>anti-glare cones before<br>each use.<br>2.Make sure that the<br>stipulated light<br>irradiance permits<br>adequate<br>polymerization. For<br>that purpose, check the | 1. Disinfect<br>contaminated surfaces<br>of the curing light as<br>well as light probes and<br>anti-glare cones before<br>each use.<br>2. Make sure that the<br>stipulated light intensity<br>permits adequate<br>polymerization. For that<br>purpose, check the light<br>probe for contamination | Different<br>Analysis (1) |
| | | | | | |
| | Start key to activate<br>light. Press once or<br>Double press to<br>select curing time .<br>5. Once the selected<br>curing time has<br>elapsed, the curing<br>program is<br>automatically<br>terminated. | cycle(s) .<br>4. Short press<br>Power/Start Button<br>to start working.<br>Once the selected<br>curing time has<br>elapsed, the curing<br>program is<br>automatically<br>terminated. | light probe for<br>contamination and<br>damage, as well as the<br>light irradiance at<br>regular intervals.<br>3.Select curing<br>program and time.<br>4.Start: Once the<br>selected curing time<br>has elapsed, the curing<br>program is<br>automatically<br>terminated. | and damage, as well as<br>the light intensity at<br>regular intervals.<br>3. Select curing<br>program and time<br>4. Start: Once the<br>selected curing time has<br>elapsed, the curing<br>program is<br>automatically<br>terminated. | |
| Delivery<br>form content | -Handpiece<br>-Charging Base<br>-Cure Tip<br>-Protection glasses<br>-Battery pack<br>-Adapter (with<br>Power Cord)<br>-Protective Sleeve<br>-User Manual | -Handpiece<br>-Charging Base<br>-Cure Tip<br>-Battery (Included<br>in the handpiece)<br>-Adapter (with<br>Power Cord)<br>-Protective Sleeve<br>-User Manual | terminated.<br>-D-Lux+ Handpiece<br>-D-Lux+ Charger<br>-Light Probe<br>-Light Protector<br>-C-Battery (Included in<br>the handpiece)<br>-Adapter<br>-Power Cord<br>-Disposable Sheaths<br>(200ea/Box)<br>-User Manual | - Charging base with<br>power cord and<br>power pack<br>- Handpiece<br>- Light probe<br>-Anti-glare shield<br>-Anti-glare cones<br>-Pack of sleeves<br>- Instructions for use | Different<br>Analysis (2) |
| Wavelength<br>range | 385 - 515 nm | | 385 – 515 nm | 385 - 515 nm | SAME |
| Use | Prescription / Hospital | | Prescription / Hospital | Prescription / Hospital | SAME |
| Operational<br>modes | 1 programs:<br>Curing light<br>Mode:10s, 20s<br>(1600 ~ 1800<br>mW/cm²) | 3 programs:<br>- Soft up mode: 5s,<br>10s, 15s, 20s (1600<br>mW/cm²)<br>- High power mode:<br>5s (1700 mW/cm²)<br>- Orthodontic<br>mode:<br>(1800 mW/cm²) | | High 1,200 mW/cm²<br>(10, 15, or 20 sec)<br>Turbo 2,000 mW/cm² (5<br>Sec) | Different<br>Analysis (3) |
| Power Supply | Adapter:<br>100V - 240V- 50 - 60 Hz<br>Output: 5V 1.5A<br>Batterycharging | | 100-240VAC, 50-60Hz,<br>Output: 6VDC/2A<br>Wirelessly Battery<br>charging | | Different<br>Analysis (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 | | |
| Photobiologic<br>al safety | IEC 62471 | IEC 62471 | / | SAME | |
| Biocompatibility | Direct contact with issue in not intended.<br>Therefore ISO10993-1 is not applicable. | Direct contact with issue in not intended.<br>Therefore ISO10993-1 is not applicable. | / | SAME | |
| Infection<br>Control | 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. | Equivalent<br>Analysis (5) | |

## Table 1 General Comparison

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#### 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.

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- 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.