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.

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

AI/ML Overview

{"1": "No specific acceptance criteria or performance metrics were reported in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on similar characteristics and non-clinical testing.", "2": "The document states "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." Therefore, no sample size for a test set or data provenance can be provided.", "3": "No clinical data was collected, thus no experts were used to establish ground truth for a test set.", "4": "No clinical data was collected, thus no adjudication method was used.", "5": "No MRMC comparative effectiveness study was done as no clinical data was collected.", "6": "A standalone study was not done; the evaluation relied on non-clinical bench testing to demonstrate conformance with harmonized standards and substantial equivalence.", "7": "The ground truth for demonstrating substantial equivalence appears to be based on compliance with harmonized standards and successful non-clinical bench testing, rather than expert consensus, pathology, or outcomes data.", "8": "No specific training set size is mentioned as no clinical data was collected or used for an algorithm.", "9": "Not applicable, as no training set was used for an algorithm."}

Summary

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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

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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 (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

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Indications for Use

510(k) Number (if known) K200809

Device Name D-Lux+

Indications for Use (Describe)

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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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 andAddress:	DiaDent Group International16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea
Contact Person:	Kab Sun LeeQuality Assurance ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: 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

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Name	Description
D-Lux+ Handpiece	This device turns on/off the power, sets the mode and time, and controls theoperation. 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 isprohibited.
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 asprecautions, operating procedures, and how to use the device.

5.5 Indications For Use

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 PredicateDevice	Discuss
510(k) Number	K200809	K190272	-
Product code	EBZ	EBZ	Equivalent
Device Class	II	II	Equivalent
Applicant	DiaDent GroupInternational	Ivoclar Vivadent, AG	-
Device Name	D-Lux+	Bluephase PowerCure	-
Indications foruse	The D-Lux+ is intendedto polymerize resinousdental materials,restorative compositematerials, andorthodontic brackets,bonding and sealingmaterials that arephoto-polymerized inthe 385~515nmwaveband of visiblelight.	With its "Polywave"broadband spectrum,Bluephase PowerCureis suitable for thepolymerization of alllight curing dentalmaterials curing in thewavelength range of385-515 nm. Thesematerials includerestoratives, bondingagents/adhesives, bases,liners, fissure sealants,temporaries, as well asluting materials forbrackets and indirectrestorations, such asceramic inlays.	Equivalent1) 385~515 nmwavelength2) polymerize resinousdental materials3) orthodontic brackets,bonding and sealingmaterials4) visible light
Principles ofoperation	1. Disinfectcontaminated surfacesof the curing light aswell as light guides andanti-glare cones beforeeach use.2. Make sure that thestipulated lightirradiance permitsadequatepolymerization. For that	1. Insert the LightProbe into the hand-piece Attach the LightProtector to the hand-piece.2. Cover the LightProbe with theDisposable Sheath.	Equivalent

	purpose, check the lightprobe for contaminationand damage, as well asthe light irradiance atregular intervals.3. Select curingprogram and time4. Start: Once theselected curing time haselapsed, the curingprogram isautomaticallyterminated.	3. Turn on the powerand select the mode andset-up time.4. Press the Operationbutton to perform lightirradiation for the settime and press thebutton once again tostop the lightirradiation. The lightirradiation progresstime is displayednumerically in thedisplay window.
Delivery form	-D-Lux+ Handpiece-D-Lux+ Charger-Light Probe-Light Protector-C-Battery (Included inthe handpiece)-Adapter-Power Cord-Disposable-Sheaths(200ea/Box)-User Manual	-Charging base withpower cord and powerPack-Handpiece-Handpiece support-Light guide 10>9 mm-Anti-glare shield-Anti-glare cones*3ea-Pack of sleeves(1x 50 pcs)-Instructions for Use	-
TechnicalSpecifications -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).
1. 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.
1. 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).
1. 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.

1. 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

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.

Regulation Number and Section

§ 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.