D-LUX+

K200809 · DiaDent Group International · EBZ · Aug 7, 2020 · Dental

Device Facts

• Record ID: K200809
• Device Name: D-LUX+
• Applicant: DiaDent Group International
• Product Code: EBZ · Dental
• Decision Date: Aug 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515mm waveband of visible light.

Device Story

D-Lux+ is a handheld LED dental curing light used by clinicians to polymerize resinous dental materials, composites, and orthodontic adhesives. The device consists of a handpiece with an integrated rechargeable lithium-ion battery, a light probe, and a wireless charging base. The clinician selects a curing mode and time via the handpiece interface; the device emits visible light in the 385-515nm range to initiate photo-polymerization. Disposable sheaths are used to mitigate cross-contamination. The device provides a controlled light output to ensure adequate material hardening, directly affecting the structural integrity of dental restorations and orthodontic bonding. It is intended for use in clinical/hospital settings.

Clinical Evidence

No clinical data was collected or provided. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and battery safety (IEC 62133).

Technological Characteristics

Handheld LED polymerization light; wavelength 385-515 nm; internal rechargeable lithium-ion battery; wireless charging; disposable sheaths for infection control. Conforms to IEC 60601-1, IEC 60601-1-6, IEC 62471, IEC 60601-1-2, and IEC 62133. Non-sterile.

Indications for Use

Indicated for polymerization of resinous dental materials, restorative composites, orthodontic brackets, bonding, and sealing materials in the 385-515nm visible light spectrum. Prescription use only.

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

• Bluephase PowerCure (K190272)

Submission Summary (Full Text)

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August 7, 2020

Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si. Chungcheongbuk-do 28161 Republic Of Korea

Re: K200809

Trade/Device Name: D-Lux+ Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: July 15, 2020 Received: July 20, 2020

Dear Kab Lee:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Srinivas "Nandu" Nandkumar Director DHT1B: Division of Dental 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) K200809

Device Name D-Lux+

Indications for Use (Describe)

The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515mm waveband of visible light.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 5.0 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

# 5.1 Application Information

| Date Prepared: | August 7, 2020 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>Address: | DiaDent Group International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Kab Sun Lee<br>Quality Assurance Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

# 5.2 Device Information

| Device Type: | Activator, Ultraviolet, For Polymerization |
|-------------------------|--------------------------------------------|
| Regulation Description: | Ultraviolet activator for polymerization. |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.6070 |
| Product Code: | EBZ |
| Device Class: | II |
| 510(k) Number | K200809 |
| Device Name: | D-Lux+ |

## 5.3 Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

| 510(k) Number: | K190272 (Primary predicate) |
|--------------------|-----------------------------|
| Applicant: | Ivoclar Vivadent, AG |
| Device Name: | Bluephase PowerCure |
| Regulation Number: | 21 CFR 872.6070 |
| Product Code: | EBZ |
| Device Class: | II |

# 5.4 Device Description

The subject device is packaged with the following:

| D-Lux+ Handpiece | D-Lux+ Charger |
|--------------------|-------------------------------|
| Light Probe | Light Protector |
| C-Battery | Adapter |
| Power Cord | Disposable Sheaths(200ea/Box) |
| Instruction Manual | |

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| Name | Description |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| D-Lux+ Handpiece | This device turns on/off the power, sets the mode and time, and controls the<br>operation. The handpiece includes a battery. |
| C-Battery | It is included in the handpiece and supplies power to the handpiece. |
| D-Lux+ Charger | Charge the battery when the handpiece is placed on this device. |
| Adapter | Supply power to the charger |
| Power Cord | A cord to conduct power to an adapter |
| Disposable sheath | Protect products and patients from contamination. Disposable, so reuse is<br>prohibited. |
| Light Probe | It is connected to the handpiece so that the light emitted from the light source (LED)<br>reaches the restoration. |
| Light Protector | It is inserted into the handpiece and used to protect the eyes from emitted light. |
| Instruction Manual | This is a document that describes information that the user needs to know, such as<br>precautions, operating procedures, and how to use the device. |

## 5.5 Indications For Use

The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.

## 5.6 Non-Clinical Performance Data

This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:

- IEC 60601-1:2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
- IEC/EN 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 62133:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- ISO 14971:2012 Risk management for medical devices
- FCC CFR 47:2008 Part 1. 1310 and 2.1093, Part 15. Subpart C Section 15.207 and 15.209

Additional non-clinical bench testing demonstrates the safety and effectiveness of the subject device.

# 5.7 Clinical Performance Data

No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.

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### 5.8 Technological characteristics

The subject device, D-Lux+ has similar characteristics to the predicate device, Bluephase PowerCure. First, the indications for use of the subject device and predicate device is polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm.

Second, both the subject device and predicate device are these materials include restoratives, and orthodontic brackets.

| | Subject Device | Primary Predicate<br>Device | Discuss |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200809 | K190272 | - |
| Product code | EBZ | EBZ | Equivalent |
| Device Class | II | II | Equivalent |
| Applicant | DiaDent Group<br>International | Ivoclar Vivadent, AG | - |
| Device Name | D-Lux+ | Bluephase PowerCure | - |
| Indications for<br>use | The D-Lux+ is intended<br>to polymerize resinous<br>dental materials,<br>restorative composite<br>materials, and<br>orthodontic brackets,<br>bonding and sealing<br>materials that are<br>photo-polymerized in<br>the 385~515nm<br>waveband of visible<br>light. | With its "Polywave"<br>broadband spectrum,<br>Bluephase PowerCure<br>is 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>1) 385~515 nm<br>wavelength<br>2) polymerize resinous<br>dental materials<br>3) orthodontic brackets,<br>bonding and sealing<br>materials<br>4) visible light |
| Principles of<br>operation | 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 that | 1. Insert the Light<br>Probe into the hand-<br>piece Attach the Light<br>Protector to the hand-<br>piece.<br>2. Cover the Light<br>Probe with the<br>Disposable Sheath. | Equivalent |
| | | | |
| | purpose, check the light<br>probe for contamination<br>and damage, as well as<br>the light irradiance at<br>regular intervals.<br><br>3. Select curing<br>program and time<br><br>4. Start: Once the<br>selected curing time has<br>elapsed, the curing<br>program is<br>automatically<br>terminated. | 3. Turn on the power<br>and select the mode and<br>set-up time.<br><br>4. Press the Operation<br>button to perform light<br>irradiation for the set<br>time and press the<br>button once again to<br>stop the light<br>irradiation. The light<br>irradiation progress<br>time is displayed<br>numerically in the<br>display window. | |
| Delivery form | -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<br>-Sheaths(200ea/Box)<br>-User Manual | -Charging base with<br>power cord and power<br>Pack<br>-Handpiece<br>-Handpiece support<br>-Light guide 10>9 mm<br>-Anti-glare shield<br>-Anti-glare cones*3ea<br>-Pack of sleeves<br>(1x 50 pcs)<br>-Instructions for Use | - |
| Technical<br>Specifications -<br>Wavelength range | 385 - 515 nm | 385 - 515 nm | Equivalent |
| Use | Prescription / Hospital | Prescription / Hospital | Equivalent |
| Sterility | Non sterile | Non sterile | Equivalent |

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## 5.9 Conclusions

#### 1) Technological characteristics

The subject device, D-Lux+ has similar characteristics to the predicate device, Bluephase PowerCure. 1) Product Code and Regulatory Classification

- : The proposed classification of the subject devices is II according to the product code, EBZ. It is the same as the predicate devices (K190272).
- 2) Indications for Use
- : Both dental curing lights are used for light curing of dental restoratives including bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.
- 3) Principle of Operation
- : The subject device is used after inserting a Light Guide) and attaching a Light Protector(Anti-glare Shield). Select the appropriate mode and time and press the operation button to perform the procedure. It is the same as the predicate devices (K190272).

4) Light Source

- : The subject device uses LED that produce a broadband spectrum of blue light in the wavelength range of 385-515nm. It is the same as the predicate devices (K190272).
5) Power Source

- : The subject device is handpiece type using an internal rechargeable lithium ion battery. It is the same as the predicate devices(K190272).
- 6) Safety Test

the product has been tested to IEC60601-1 and IEC 60601-1-1-2 and meets the requirements for Electrical Safety, Including US National Deviations, and Electromagnetic compatibility. The test reports are included in this submission.

- 7) Biocompatibility
Direct contact with issue in not intended. Therefore ISO10993-1 is not applicable.

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() Differences between Subject Devices and Predicates Devices

1) Operation Modes and Light Intensity

: 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, IEC60601-1-2 and FDA guidance performance testing requirements with the difference. The testing results show that these difference do not affect safety and effectiveness .

2) Cross Infection Prevent

: The subject device uses disposable sheath and surface disinfection to prevent cross infection of the patient, which is substantially equivalent to the primary predicate device.

3) Battery Charging and Power Supply

: The subject device is wirelessly charged without a contact using a wireless charger. However, the predicate device is charged by the charging method by the contact. 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, max 1A) are the same, but the outputs differ from each other at 6VDC/2A and 5VDC/3A respectively. These difference do not affect safety and effectiveness .

#### 4) Light Probe

: The target device uses a light probe with an embedded LED. However, the predicate device uses a light guide. These difference do not affect safety and effectiveness .

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.

D-Lux+ is an LED polymerization light, which is used for the polymerization of light-curing dental materials. This is achieved by using the same operating principle and performance criteria as for Bluephase PowerCure. Therefore, D-Lux+ is substantially equivalent to its predicate device, Bluephase PowerCure.