The D1 LED Curing Light & accessories is intended to polymerize resinous dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430~490nm waveband of visible light.

Device Description

D1 by DXM Co., Ltd. is classified as an Ultraviolet Activator for polymerization (21 CFR 872.6070) because it is a device intended for the photopolymerization light cured dental materials. The D1-Cordless is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490nm waveband of spectrum with a power density of 3,000mW/cm² (11-8mm light-guide). These power densities are sufficient for the product intended uses, namely, Photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials, restorative composite materials, and orthodontic brackets and orthodontic bonding and sealing materials.

D1 has two operating modes: Plasma Emulation/ Ortho mode: 3000 mW/cm² and High Power mode: 1500 mW/cm2.

Exposure timing intervals for Plasma Emulation mode is 1, 2, 3 seconds, Ortho: approximately 3 seconds on, 1 second off for 16 cycles and High Power mode: 5, 10, 20, 40 seconds.

The D1 Curing light is cordless and is powered by a rechargeable Lithium-lon battery which is charged by a Battery Charger Stand supplied with a certified AC/DC Adapter.

AI/ML Overview

The provided text describes the 510(k) submission for the D1 LED Curing Light, which is a device intended to polymerize resinous dental materials. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes non-clinical bench tests performed to verify specific technical aspects of the device against established standards and expected performance for similar devices.

Acceptance Criterion (Inferred from testing)	Reported Device Performance
Verification of Spectral Irradiance Output	Confirmed as part of testing
Verification/Validation of Irradiance Intensity	Confirmed as part of testing (specifically, 3,000mW/cm² for Plasma Emulation/Ortho mode and 1,500mW/cm² for High Power mode)
Depth of Cure	Confirmed as part of testing
Verification of Case Temperature Rise	Confirmed as part of testing
Compliance with IEC 60601-1: 1988 +A1 1991, +A2 1995	Met through testing
Compliance with ANSI/AAMI/IEC 60601-1-2: 2007	Met through testing
Biocompatibility (ISO 10993-5 and ISO 10993-10)	Met through testing

Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical data for performance evaluation in the way one would for a diagnostic or AI algorithm. Instead, it refers to non-clinical bench tests. For these bench tests, sample sizes are not explicitly stated. The data provenance is from non-clinical bench testing conducted in a lab setting, likely by DXM Co., Ltd. or a contracted testing facility. No country of origin for a clinical data set is applicable as no clinical studies were performed.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth in the context of expert consensus on clinical cases was established, as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the specifications derived from the predicate devices and relevant standards.
Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication was used.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a dental curing light device.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The D1 LED Curing Light is a physical device, not an algorithm. The "standalone" performance refers to the device's technical specifications and functionality, which were evaluated through bench testing.
Type of Ground Truth Used:

The "ground truth" for this submission is based on engineering specifications, established international and national standards (e.g., IEC 60601-1, ANSI/AAMI/IEC 60601-1-2, ISO 10993-5, ISO 10993-10), and the performance characteristics of predicate devices. For example, the irradiance intensity of 3,000mW/cm² (Plasma Emulation/Ortho mode) and 1,500mW/cm² (High Power mode) would be a performance characteristic verified against the device's design specifications, which are implicitly derived from the requirements for effectively polymerizing dental materials and the performance of predicate devices.
Sample Size for the Training Set:

Not applicable. There is no "training set" as this device does not involve machine learning or AI algorithms requiring data for training.
How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

KIN 1093

Image /page/0/Picture/1 description: The image shows a logo with a stylized crescent shape on the left and the letters "dxm" on the right. The crescent shape is filled with a textured pattern and has a small oval shape underneath it. The letters "dxm" are in a simple, sans-serif font and are positioned close to the crescent shape.

Section 3: 510(k) Summary

NOV 2 7 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Submitter's Identification: 1.

DXM Co., Ltd. 1003, Ilsantechnotown Bldg. Baeksuk1-Dong, Ilsandong-Gu, Goyang-City Republic of Korea 410-722 Telephone - 82 31 909-8275 Fax - 82 31 909-8276 Contact - Sun Hwa Song, Chief Officer

Date Summary Prepared: April 9, 2012

2. Name of Device:

Trade/Proprietary Name:

D1 LED Curing Light SPEC 3 Dentronix LED 3000

Classification Name:

Activator, Ultraviolet, for Polymerization

Class in which Device has been placed:

The Dental devices panel has classified this device as Class II, 21 CFR Part 872.6070, Product Code EBZ.

1. Predicate Device Information:

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with a stylized crescent shape on the left and the letters 'dxm' on the right. The crescent shape is textured and has a horizontal oval shape underneath it. The letters 'dxm' are in a simple, sans-serif font and are aligned horizontally.

The D1 LED Curing Light is substantially equivalent to:

Cybird LED curing light (K042703) .
Coltolux LED (K040551) .
Valo Cordless (K110582) ●

Device Description: 4.

D1 has two operating modes: Plasma Emulation/ Ortho mode: 3000 mW/cm² and High Power mode: 1500 mW/cm2.

Exposure timing intervals for Plasma Emulation mode is 1, 2, 3 seconds, Ortho: approximately 3 seconds on, 1 second off for 16 cycles and High Power mode: 5, 10, 20, 40 seconds.

The D1 Curing light is cordless and is powered by a rechargeable Lithium-lon battery which is charged by a Battery Charger Stand supplied with a certified AC/DC Adapter.

5. Indication for Use:

ર. Substantial Equivalence:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo with a stylized crescent shape on the left and the letters 'dxm' on the right. The crescent shape is filled with a textured pattern, and there is a small oval shape underneath it. The letters 'dxm' are in a simple, sans-serif font and are positioned close together.

The DXM D1 LED curing light has similar characteristics and intended use as previously cleared device, K042703 Cybird LED curing light, Coltolux LED (K040551) and Valo Cordless (K110582) for the photo-polymerization of dental materials, restorative composite materials ,and polymerization of bonding and sealing materials .

These devices are well established and determined to be safe and effective.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing that was conducted in accordance with IEC 60601-1: 1988 +A1 1991,+A2 1995; ANSI/AAMI/IEC 60601-1-2: 2007; supports testing information demonstrating safety and effectiveness of the D1-Cordless LED Curing Light in the intended environment of use. Biocompatibility testing conducted based on ISO 10993-5 and ISO 10993-10.

Non-clinical Bench Test performed as following:

Verification Spectral Irradiance output .
Verification/ Validation of Irradiance Intensity .
Depth of Cure .
Verification of case Temperature Rise

None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.

7. Discussion of Clinical Tests Performed:

No clinical testing was conducted.

8. Conclusions:

The D1-Cordless LED Curing Light is substantially similar to the predicate in intended use, operation, safety and function, and is safe and effective for its' intended use.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, positioned to the right of a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the seal.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DXM Company, Limited C/O Mr. Jigar Shah MDI Consultants, Incorporated 55 Northern Boulevard Great Neck, New York

NOV 2 7 2012

Re: K121093

Trade/Device Name: D1 LED Curing Light or SPEC 3 or LED 3000 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 25, 2012 Received: October 26, 2012

Dear Mr. Shah:

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. 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.

{4}------------------------------------------------

Page 2 - Mr. Shah

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital,

Respiratory, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo with a stylized crescent shape on the left and the letters 'dxm' on the right. The crescent shape is black and textured, with a small oval shape underneath it. The letters 'dxm' are in a simple, rounded font and are also black. The overall design is clean and modern.

Section 2: Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name: D1 LED Curing Light or SPEC 3 or LED 3000

Indications For Use:

2012.11.27

-05'00'

Susan Runner DDS, MAN 1 3:38:28

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Prescription Use X (Per 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.