(465 days)
No
The description focuses on standard dental curing light technology, including LED illumination, optical technology, a microprocessor for control, and basic user interface elements. There is no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML applications in medical devices.
No.
The device cures dental restorative materials and adhesives, which are not directly treating a disease or condition in a therapeutic manner for a human body.
No
Explanation: The device is described as a curing light for dental restorative materials, implying a therapeutic or procedural function rather than a diagnostic one. Its purpose is to polymerize materials, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components (handpiece, charging stand, barrier sleeves, light shields, power adapter) and mentions hardware verification and validation in the performance studies section.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Source of illumination for curing photo-activated dental restorative materials and adhesives." This describes a device used in vivo (on a patient) to solidify dental materials, not a device used in vitro (outside the body) to examine specimens.
- Device Description: The description details a dental curing light system used to polymerize dental materials. This is a common dental procedure performed directly on the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for use in a dental setting to facilitate a dental procedure on a patient.
N/A
Intended Use / Indications for Use
Source of illumination for curing photo-activated dental restorative materials and adhesives.
Product codes
EBZ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary for FUSION Plus Curing Lights
1. APPLICANT
Dentli
DentLight Inc. 1825 Summit Ave., Suite 210 Plano, TX 75074
Phone: 972-889-8857 Fax: 972-346-6550 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
1
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
Predicate Device) | FUSION
(Reference Device) |
|----------------------------------|------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | Source of illumination
for curing photo-
activated dental
restorative materials
and adhesives | Source of illumination
for curing photo-
activated dental
restorative materials
and adhesives | Photopolymerization of dental resins,
restorative composite materials, and
orthodontic brackets, bonding, and
sealing that are photo-polymerized in
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
Classification | | Ultraviolet activator
for polymerization | Ultraviolet activator
for polymerization | Ultraviolet activator
for polymerization |
| Light Source | | High-power LED | High-power LED | High-power LED |
| Power Supply | | Input: 100-240V -
50/60Hz; Output: 5V
1-2A | Input: 100-
240VAC@50-60Hz;
Output: 12V 5A | Input: 100-240V - 50/60Hz; Output: 5V
1-2A |
| Peak Wavelength Range | | 395-480
(Plus head)
440-480 nm
(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,
plastic barrier control
and light shield | Aluminum body,
plastic barrier control
and light shield | Aluminum body, plastic barrier control
and light shield |
| Compliance Standards | | IEC 60601-1; IEC
60601-1-2 | IEC 60601-1; IEC
60601-1-2 | IEC 60601-1; IEC 60601-1-2 |
2
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
3
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)
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."
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Image /page/5/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 & 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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