FUSION Plus Curing Light

K180065 · Dentlight, Inc. · EBZ · Apr 19, 2019 · Dental

Device Facts

• Record ID: K180065
• Device Name: FUSION Plus Curing Light
• Applicant: Dentlight, Inc.
• Product Code: EBZ · Dental
• Decision Date: Apr 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2

Intended Use

Source of illumination for curing photo-activated dental restorative materials and adhesives.

Device Story

Portable dental LED curing light system; provides illumination for polymerization of photo-activated dental materials. System includes handpiece, charging stand, barrier sleeves, light shields, and power adapter. Handpiece features aluminum construction, rechargeable battery, and interchangeable LED light heads (395-480nm or 440-480nm). Operator uses LCD display and two buttons to select timer and curing modes (plasma or pulse). Device used in dental clinics by dental professionals. Light shield and barrier sleeves provide eye protection and infection control. High-power LED technology delivers curing light to restorative materials; facilitates efficient polymerization. Benefits include improved ease of use via modular swivel head design and effective curing across various dental material photoinitiator ranges.

Clinical Evidence

Bench testing only. Performance evaluated per FDA guidance 'Dental Curing Lights – Premarket Notification [510(k)] Submissions'. Testing included optical irradiance, spectral irradiance, curing time, curing modes, heat management, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and ANSI/ADA 48-2 compliance. Software and hardware verification/validation and risk analysis were performed.

Technological Characteristics

Portable LED curing light; aluminum handpiece body; rechargeable lithium-ion battery. Interchangeable LED heads; peak wavelengths 395-480nm or 440-480nm. Microprocessor-controlled user interface with LCD and two buttons. Compliance: IEC 60601-1, IEC 60601-1-2, ANSI/ADA 48-2. Non-sterile; uses barrier sleeves for infection control.

Indications for Use

Indicated for use as a source of illumination for curing photo-activated dental restorative materials and adhesives in dental patients.

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

• Valo (K083647)

Reference Devices

• FUSION (K052593)

Submission Summary (Full Text)

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# 510(k) Summary for FUSION Plus Curing Lights

#### 1. APPLICANT

K180065

Dentli

DentLight Inc. 1825 Summit Ave., Suite 210 Plano, TX 75074

Phone: [phone] Fax: [phone] Contact Person: Richard Liu Date Prepared: April 19, 2019

#### 2. DEVICE NAME

Proprietary Name: FUSION Plus Curing Light Common/Usual Name: Dental Curing Light Classification Name: Ultraviolet activator for polymerization (872.6070) Product Code: EBZ

#### 3. PRIMARY PREDICATE DEVICE

Valo (K083647), manufactured by Ultradent Products, Inc

#### REFERENCE DEVICE

FUSION (K052593), manufactured by DentLight Inc.

#### 4. INTENDED USE / INDICATIONS FOR USE

Source of illumination for curing photo-activated dental restorative materials and adhesives.

# 5. DEVICE DESCRIPTION

Fusion Plus Curing Light is a portable dental LED curing light system. It provides a source of illumination for polymerization of photo-activated dental materials. The principle of operation is the same as the predicate devices: illumination for polymerization or curing of photo-activated dental materials. It uses our patented Fusion optical technology in combination with high-power LED to deliver high efficiency and high-power curing light.

The system consists of a curing handpiece, a charging stand, 100 barrier sleeves, light shields, a power adapter, and instructions for use. The handpiece is constructed of aluminum and consists of a main control, a light head, and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface consisting of LCD display and two control buttons. A mode button selects operation timer and two curing modes: plasma or pulse mode. A ON/OFF button activates and deactivates the light. The handpiece is non-sterile utilizing the barrier sleeves for infection control. Similar to the predicate devices, the light shield and curing cap absorb emitted light

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Image /page/1/Picture/0 description: The image shows the logo for "DentLight". The word "Dent" is in gray, while "Light" is in blue. There is a light blue glow above the "i" in "Light".

and perform the function of eye protection. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery. FUSION Plus has an interchangeable LED light head. Depending on the light head connected with the main control or added later, the kit can be configured in three options:

| Trade Name | LED Peak Wavelength (nm) |
|-------------------------------------------------------------------------------------|--------------------------|
| FUSION Plus | 395-480 |
| FUSION Plus Standard | 440-480 |
| The instructions for use detail the use of each head in curing of dental materials. | |

# 6. DEVICE CHARACTERISTICS AND SUBSTANDTIAL EQUIVALENCE

FUSION Plus is substantially equivalent to the predicate device Valo (K083647) manufactured by Ultradent Products Inc. and FUSION (K052593) designed and manufactured by DentLight Inc. A comparison table with the predicate and reference devices lists key features and characteristics of the subject and predicate devices. It shows the product to be substantially equivalent to the predicate devices.

| Parameter | | FUSION Plus | Valo (Primary<br>Predicate Device) | FUSION<br>(Reference Device) |
|----------------------------------|------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | Source of illumination<br>for curing photo-<br>activated dental<br>restorative materials<br>and adhesives | Source of illumination<br>for curing photo-<br>activated dental<br>restorative materials<br>and adhesives | Photopolymerization of dental resins,<br>restorative composite materials, and<br>orthodontic brackets, bonding, and<br>sealing that are photo-polymerized in<br>the 440-480nm wavelength range |
| 510(k) Number | | K180065 | K083647 | K052593 |
| Product Code | | EBZ | EBZ | EBZ |
| Regulation Number | | 21 CFR 872.6070 | 21 CFR 872.6070 | 21 CFR 872.6070 |
| Device Class | | II | II | II |
| Common Name of<br>Classification | | Ultraviolet activator<br>for polymerization | Ultraviolet activator<br>for polymerization | Ultraviolet activator<br>for polymerization |
| Light Source | | High-power LED | High-power LED | High-power LED |
| Power Supply | | Input: 100-240V -<br>50/60Hz; Output: 5V<br>1-2A | Input: 100-<br>240VAC@50-60Hz;<br>Output: 12V 5A | Input: 100-240V - 50/60Hz; Output: 5V<br>1-2A |
| Peak Wavelength Range | | 395-480<br>(Plus head)<br>440-480 nm<br>(Plus Standard) | 395-480 nm | 440-480 nm |
| Curing Optical | Plasma | 4000 | 4500 | 2700 |
| Intensity | Pulse/high | 2000 | 1400 | 1350 |
| mW/cm² | Standard | NA | 1000 | NA |
| User Control Interface | | 2 Buttons | 2 Buttons | 2 Buttons |
| Weight (grams) | | 112 | 75 grams | 111 |
| Battery | | Lithium ion | NA | Lithium ion |
| Structure | | Ergonomic wand | Ergonomic wand | Ergonomic wand |
| Materials | | Aluminum body,<br>plastic barrier control<br>and light shield | Aluminum body,<br>plastic barrier control<br>and light shield | Aluminum body, plastic barrier control<br>and light shield |
| Compliance Standards | | IEC 60601-1; IEC<br>60601-1-2 | IEC 60601-1; IEC<br>60601-1-2 | IEC 60601-1; IEC 60601-1-2 |

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Similarities between the FUSION Plus Curing Light and Valo:

- · The FUSION Plus has the same indications for use as the primary predicate device Valo.
- · The FUSION Plus has substantially equivalent curing modes as the primary predicate device Valo.
- · The FUSION Plus has substantially equivalent performance characteristics as the primary predicate device Valo.
- · The FUSION Plus is substantially equivalent to the primary predicate device Valo in standards compliance.

### Differences between the FUSION Plus Curing Light and Valo:

The primary predicate Valo has a uni-body construction with a fixed aluminum body. The FUSION Plus has a modular aluminum body construction with a swivel interchangeable light head. Plus Head and Plus Standard Head. The Plus Head has a wavelength range of 395- 480nm that is the same as the primary predicate Valo and wider than the reference device FUSION. These wavelengths cover VLC materials with photoinitiator sensitive to all photoactivated dental materials (395- 480mm). The difference in construction improves the operator's ease of use and does not raise any substantial equivalence concerns as it has the same wavelengths of the primary predicate Valo.

## Similarities between the FUSION Plus Curing Light and the reference device FUSION:

- · The FUSION Plus and the reference device FUSION has the same construction. FUSION Plus Standard Head has the same center wavelengths of 440 nm - 480 nm as the reference device FUSION. The wavelengths cover VLC materials with photoinitiators sensitive to photoactivated dental materials in the 440 nm - 480 nm (CQ and PPD).
- · The FUSION Plus and the reference device FUSION use the same optoelctronic design, FUSION optical beam technology, and construction materials except the Plus Head LED.

Both FUSION Plus head and FUSION Plus Standard head are powered and controlled by the same main control under the same condition with the only difference being the choice of LED and its placement. These differences do not raise concerns about safety and effectiveness as the performances are similar to the primary predicate device and the reference device.

# 7. NON-CLINICAL PERFORMANCE TESTING

The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of the FUSION Plus Curing Light to the predicate device as suggested by the FDA's guidance for industry and FDA staff titled "Dental Curing Lights – Premarket Notification [510(k)] Submissions" issued on March 27, 2006:

- · device performance
- o optical irradiance
- o spectral irradiance
- o curing time
- o curing modes and safety controls
- o heat management
- · software and hardware verification and validation,
- · risks to health and traceability analysis
- · electrical safety and electromagnetic compatibility

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Image /page/3/Picture/0 description: The image shows the logo for DentLight. The word "Dent" is in gray, and the word "Light" is in blue. There is a small, light blue circle above the "i" in "Light."

FUSION Plus complies with the electrical and optical safety requirements as the predicate devices: IEC 60601-1, IEC 60601-1-2, and ANSI/ADA 48-2.

## 8. CONCLUSION

Based on similarities in indications for use and technology together with results from performance testing, we believe that FUSION Plus Curing Light is substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180062

Device Name FUSION Plus Curing Light

Indications for Use (Describe) Source of illumination for curing photo-activated dental restorative materials and adhesives

Trade Name FUSION Plus FUSION Plus Standard

| 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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April 19, 2019

DentLight Inc. Richard Liu President 1825 Summit Ave. Ste 210 Plano, Texas 75074

Re: K180065

Trade/Device Name: FUSION Plus Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: March 19, 2019 Received: March 20, 2019

Dear Richard Liu:

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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 : 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure