(133 days)
Not Found
No
The device description and performance studies focus on the physical components and light polymerization function, with no mention of AI/ML terms or data processing capabilities.
No.
The device's intended use is to polymerize dental materials, which is a functional process rather than a direct therapeutic intervention on a patient's disease or condition. It facilitates a dental procedure (restoration) but does not treat a disease in itself.
No.
The device's intended use is to polymerize resinous dental materials, which is a treatment function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a handpiece, charger, light probe, battery, adapter, and power cord.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials". This describes a process performed on materials used in dental procedures, not a test performed on biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Device Description: The description details a light-curing device and its components. There is no mention of reagents, sample handling, or any other elements typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health.
- Measuring analytes in a sample.
The device is a dental light-curing unit, which is a therapeutic or procedural device used in dentistry.
N/A
Intended Use / 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 385~515mm waveband of visible light.
Product codes
EBZ
Device Description
The subject device is packaged with the following:
D-Lux+ Handpiece
Light Probe
C-Battery
Power Cord
Instruction Manual
D-Lux+ Charger
Light Protector
Adapter
Disposable Sheaths(200ea/Box)
Name: D-Lux+ Handpiece
Description: This device turns on/off the power, sets the mode and time, and controls the operation. The handpiece includes a battery.
Name: C-Battery
Description: It is included in the handpiece and supplies power to the handpiece.
Name: D-Lux+ Charger
Description: Charge the battery when the handpiece is placed on this device.
Name: Adapter
Description: Supply power to the charger
Name: Power Cord
Description: A cord to conduct power to an adapter
Name: Disposable sheath
Description: Protect products and patients from contamination. Disposable, so reuse is prohibited.
Name: Light Probe
Description: It is connected to the handpiece so that the light emitted from the light source (LED) reaches the restoration.
Name: Light Protector
Description: It is inserted into the handpiece and used to protect the eyes from emitted light.
Name: Instruction Manual
Description: This is a document that describes information that the user needs to know, such as precautions, operating procedures, and how to use the device.
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
Prescription / Hospital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Performance Data: No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 | |
| Address: | DiaDent Group International |
| 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea | |
| Contact Person: | Kab Sun Lee |
| Quality Assurance Manager | |
| Phone: +82-43-266-2315 | |
| FAX: +82-43-235-2315 | |
| Email: diadent32@diadent.co.kr |
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 |
4
| Name | Description |
|---|---|
| D-Lux+ Handpiece | This device turns on/off the power, sets the mode and time, and controls the |
| 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 |
| prohibited. | |
| Light Probe | It is connected to the handpiece so that the light emitted from the light source (LED) |
| 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 |
| 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
Device | Discuss |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200809 | K190272 | - |
| Product code | EBZ | EBZ | Equivalent |
| Device Class | II | II | Equivalent |
| Applicant | DiaDent Group
International | Ivoclar Vivadent, AG | - |
| Device Name | D-Lux+ | Bluephase PowerCure | - |
| 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. | With its "Polywave"
broadband spectrum,
Bluephase PowerCure
is suitable for the
polymerization of all
light curing dental
materials curing in the
wavelength range of
385-515 nm. These
materials include
restoratives, bonding
agents/adhesives, bases,
liners, fissure sealants,
temporaries, as well as
luting materials for
brackets and indirect
restorations, such as
ceramic inlays. | Equivalent
- 385~515 nm
wavelength - polymerize resinous
dental materials - orthodontic brackets,
bonding and sealing
materials - visible light |
| Principles of
operation | 1. Disinfect
contaminated surfaces
of the curing light as
well as light guides and
anti-glare cones before
each use.
-
Make sure that the
stipulated light
irradiance permits
adequate
polymerization. For that | 1. Insert the Light
Probe into the hand-
piece Attach the Light
Protector to the hand-
piece. -
Cover the Light
Probe with the
Disposable Sheath. | Equivalent |
| | | | |
| | purpose, check the light
probe for contamination
and damage, as well as
the light irradiance at
regular intervals. -
Select curing
program and time -
Start: Once the
selected curing time has
elapsed, the curing
program is
automatically
terminated. | 3. Turn on the power
and select the mode and
set-up time. -
Press the Operation
button to perform light
irradiation for the set
time and press the
button once again to
stop the light
irradiation. The light
irradiation progress
time is displayed
numerically in the
display window. | |
| Delivery form | -D-Lux+ Handpiece
-D-Lux+ Charger
-Light Probe
-Light Protector
-C-Battery (Included in
the handpiece)
-Adapter
-Power Cord
-Disposable
-Sheaths(200ea/Box)
-User Manual | -Charging base with
power cord and power
Pack
-Handpiece
-Handpiece support
-Light guide 10>9 mm
-Anti-glare shield
-Anti-glare cones*3ea
-Pack of sleeves
(1x 50 pcs)
-Instructions for Use | - |
| Technical
Specifications -
Wavelength range | 385 - 515 nm | 385 - 515 nm | Equivalent |
| Use | Prescription / Hospital | Prescription / Hospital | Equivalent |
| Sterility | Non sterile | Non sterile | Equivalent |
6
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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).
-
- 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.
-
- 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).
- 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).
- Power Source
- : The subject device is handpiece type using an internal rechargeable lithium ion battery. It is the same as the predicate devices(K190272).
-
- 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.
-
- Biocompatibility
Direct contact with issue in not intended. Therefore ISO10993-1 is not applicable.
- Biocompatibility
8
() Differences between Subject Devices and Predicates Devices
- 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 .
- 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.
- 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.