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 420~490nm waveband of visible light.

Device Description

The D-Lux is a cordless LED curing light, which is intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod. It is portable and battery rechargeable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the D-LUX device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Depth of Cure (via ISO 4049:2000)	2.91mm (D-LUX)

Notes:

The document primarily relies on substantial equivalence to a predicate device (Cybird LED Curing Light).
The key performance metric explicitly stated and compared is the depth of cure. The predicate device's depth of cure was 2.97mm, demonstrating the D-LUX device's comparable performance.
The D-LUX also conforms to IEC 60601-1, IEC 60601-1-2, and ADA 48[2009] standards; however, specific acceptance values for these standards are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not explicitly state the sample size used for the depth of cure test.

Data Provenance: Not specified, but given the manufacturer is based in Korea and the testing aligns with international standards (ISO and IEC), it's likely the testing was conducted either in Korea or at a certified lab. The document does not indicate if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the study described is a technical performance test (depth of cure measurement for a dental curing light) rather than a study requiring expert-established ground truth for diagnostic or interpretative tasks.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study focused on the technical performance of the device itself (depth of cure) and its equivalence to a predicate device, not on human reader performance with or without the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the D-LUX is a physical medical device (dental curing light), not an algorithm or AI solution. The "standalone" performance here refers to the device's intrinsic functional capabilities, which are assessed through the depth of cure test.

7. The Type of Ground Truth Used

The "ground truth" for the depth of cure test is established by the standardized measurement protocol outlined in ISO 4049:2000. This standard dictates how the depth of cure is measured, making the measurement itself the "ground truth" for the device's performance in this specific parameter.

8. The Sample Size for the Training Set

This information is not applicable as the D-LUX is a medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable (see point 8).

Summary

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K130163

Serving 109 countries around the world

510(k) Summary

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

Date: July 19, 2013

Company and Correspondent making the submission:

AUG 16 2013

	Company
Name	Diadent Group International
Address	626, Yeonje-ri, Gangoe-myeon, Cheongwon-gun,Chungcheong buk-do, Korea, 363-951
Phone	+82 43-266-2315
Fax	+82 43-262-8658
Contact	Gil Jun, Hong

2. Device:

Proprietary Name: D-LUX Common Name: Dental visible light curing unit Classification Name - Ultraviolet activator for polymerization

1. Predicate Device:
  Cybird LED Curing Light, K042703
1. Classifications Names & Citations: EBZ, 872.6070
1. Description:

6. Indication for use:

The D-LUX is intended to polymerize resinous dental materials, restorative

Image /page/0/Picture/17 description: The image shows several certification logos. The first logo is the TUV SUD certification mark. Next to it is the CE marking with the number 0197. The image also contains the ISO 9001 and ISO 13485 certification marks.

DiaDent Group Internatio Songiuna-Dona Heungduk-1-290 Choonachong Buk-Do. Kore 82-43 266-2315 Fax:82-43 26 http://www.diadent.co.kr e-mail:diadent@

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Serving 109 countries around the world

composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 420~490nm waveband of visible light.

7. Review:

The D-LUX has the same device characteristics as the predicate device, the Cybird LED Curing Light; indication, material, design and use concept are similar.

The D-LUX conforms to IEC 60601-1 Medical electric equipment, Part 1: General requirements for safety and IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility, ISO 4049 and ADA 48[2009] Visible light curing units. The testing result on the depth of cure by ISO 4049:2000 shows the substantially equivalence - D-Lux (new device) 2.91mm and Cybird (predicate device) 2.97mm.

Based on the comparison of intended use and technical features, the D-LUX is substantially equivalent to the predicate device.

1. Conclusions:
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Diadent Group International Inc. concludes that the D-LUX is safe and effective and substantially equivalent to predicate devices as described herein.
1. Diadent Group International will update and include in this summary any other information deemed reasonably necessary by the FDA.
  END

Image /page/1/Picture/11 description: The image contains several certification logos. On the left is the TUV SUD logo, followed by the CE marking with the number 0197. To the right are two black oval logos with white text, one reading "ISO 9001" and the other "ISO 13485".

DiaDent Group International 19-9 Songjung-Dong Heungduk-Gu Chongju-City 361-290 Choongchong Buk-Do, Korea. Fax:82-43 262-8658 Tel:82-43 266-2315 http://www.diadent.co.kr e-mail:diadent@chol.com

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wavy lines representing its body and wings. The eagle is oriented to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

August 16, 2013

Diadent Group International C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook IL 60062

Re: K130163

Trade/Device Name: D-LUX Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codc: EBZ. Dated: July 31, 2013 Received: August 7, 2013

Dear Mr. Devinc:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regally the enactment date of the Medical Device Amendments. Or to commerce prof to May 20, 1978, the oncordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosment Act (?ver) that do not require to the general controls provisions of the Act. The f ou may, therefore, market the detirements for annual registration, listing of general controls provisions of the rective, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract fiability adtincration. Thease note: CDNY does not overaliate must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) into states wills will and the cline your device can be may be subject to additions, Title 21. Parts 800 to 898. In addition. FDA may found in the Sode of receinants concerning your device in the Federal Register.

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Page 2 - Mr. Devine

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130163 510(k) Number K _

Device Name: D-LUX

Indication 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 420-490nm waveband of visible light.

Over-The-Counter Use OR Prescription Use_ (Per 21CFR807 Subpart C) (Per 21CFR801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Mary S. Runner -S ം മു 2013.08.16 15:18:56 -04'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510 (k) Number: ______________________________________________________________________________________________________________________________________________________________

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.