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

Device Description

Cybird by DXM Co., LTd is classified as an Ultraviolet Activator for polymerization(21 C.f.r.872.6070) because it is a device intended for the photo-polymerization light cured dental materials. The Cybird is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490nm waveband of spectrum with a power density comprised 1,000W/cm², 11-8mm light-guide).These power densities are sufficient for the product intended uses ,namely, Photopolymerization in the 440-490 nm waveband of visible light cured (VLC) dental materials , Photo – polymerization in the 440-490nm waveband of visible light cured(VLC) restorative composite materials, and Photo-polymerization in the 440-490 nm waveband of visible light cured (VLC) orthodontic brackets and orthodontic bonding and sealing materials. Exposure times can be set for 5,10,15, or 20 seconds.

AI/ML Overview

The DXM Co., Ltd. Cybird LED Curing Light is a device intended for the photo-polymerization of light-cured dental materials. The submission states that no clinical testing was conducted to establish its safety and effectiveness. Instead, the device's substantial equivalence to a predicate device, the Satelec Mini L.E.D (K032465), was demonstrated through non-clinical testing.

Therefore, the following information cannot be extracted from the provided text: A table of acceptance criteria and the reported device performance, sample size used for the test set and data provenance, number of experts for ground truth and qualifications, adjudication method, MRMC comparative effectiveness study results, standalone performance, type of ground truth used, sample size for training set, and how ground truth for the training set was established.

However, based on the provided text, the following details regarding the acceptance criteria and the study that "proves" the device meets them can be summarized:

Non-Clinical Acceptance Criteria and Reported Performance (via equivalence to a predicate device):

The acceptance criteria for the Cybird LED Curing Light were not explicitly stated as quantitative thresholds for performance metrics. Instead, the device's acceptability was based on demonstrating substantial equivalence to a legally marketed predicate device (Satelec Mini L.E.D, K032465) through non-clinical testing. This implies that the device's performance, as measured by these non-clinical tests, should be comparable to or within acceptable limits relative to the predicate device and established safety standards.

Acceptance Criteria Category	Reported Device Performance (via Non-Clinical Testing)
Intended Use	Demonstrated substantial similarity to the predicate device in its intended use, which is the photo-polymerization of resinous dental materials, restorative composite materials, and orthodontic brackets, bonding, and sealing materials that are photo-polymerized in the 430-490 nm waveband of visible light.
Operational Characteristics	Produces visible blue light in the 440 to 490nm waveband of spectrum with a power density comprised of 1,000W/cm² (11-8mm light-guide). Exposure times can be set for 5, 10, 15, or 20 seconds. These power densities are sufficient for the intended uses.
Safety - Electrical Safety	Conforms to EN 60601-1: 1990 +A,+B. No design characteristics violated the requirements of this standard or resulted in safety hazards.
Safety - Electromagnetic Compatibility (EMC)	Conforms to EN 60601-1-2: 2001, EN 61000-3-2:2000, EN61000-3-3: 1998/A1:2001, and EN 55011: 1998/A1:1999, Class B. No design characteristics violated the requirements of these standards or resulted in safety hazards.
Function	Demonstrated substantial similarity to the predicate device without any design characteristics violating standard requirements or resulting in safety hazards.

Study Information (Non-Clinical Equivalence Study):

Sample size used for the test set and the data provenance: Not applicable in the traditional sense of a clinical trial. The "test set" consisted of the Cybird LED Curing Light itself, undergoing various engineering and electrical safety tests. The "data provenance" is from these specific non-clinical tests performed on the device by DXM Co., Ltd. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, was established by compliance with international and national standards for electrical safety and electromagnetic compatibility (e.g., EN 60601-1, EN 61000 series, EN 55011). These standards themselves are established by expert consensus in their respective fields, but no specific number or qualification of experts for this particular device's testing is mentioned beyond the presumption that the company performing the tests had qualified personnel.
Adjudication method: Not applicable. The process was one of compliance testing against defined standards. Either the device met the standard (passed) or it did not (failed). There was no independent adjudication of test outcomes by multiple parties mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an LED curing light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a standalone hardware product for polymerization, not an algorithm.
The type of ground truth used: The ground truth for proving the device's safety and effectiveness was based on compliance with established international and national standards for electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2, EN 61000 series, EN 55011), and demonstration of functional equivalence (power output, wavelength) to the predicate device for its intended use.
The sample size for the training set: Not applicable. There was no machine learning model or algorithm to train.
How the ground truth for the training set was established: Not applicable, as there was no training set.

Summary

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OCT 1 2 2004

EXHIBIT 1

510(k) Summary

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Submitter's Identification:

DXM Co., Ltd. 1016, Ilsantechnotown Baeksuk-Dong, Ilsan-Gu, Goyang-City Republic of Korea 411-360 Telephone - 82 31 909-8275 Fax - 82 31 909-8276 Internet – http://www.dxm.co.kr Contact - Lewis Baek

Date Summary Prepared: July 27, 2004

Name of Device: 2.

Trade/Proprietary Name:

Cybird LED Curing Light

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.

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Predicate Device Information: 3.

Mini L.E.D by SATELEC (K032465)

Description and Intended Use: 4.

Exposure times can be set for 5,10,15, or 20 seconds.

5. Substantial Equivalence:

The DXM Cybird L.E.D product has similar characteristics and intended uses as the 510(k) cleared light curing units ,the Satelec Mini L.E.D Mini L.E.D (K032465) 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.

Discussion of Non-Clinical Tests Performed for Determination of 6. Substantial Equivalence are as follows:

Testing that was conducted in accordance with EN 60601-1: 1990 +A,+B; ,EN 60601-1-2: 2001; ,EN 61000-3-2:2000 and EN61000-3-3 , 1998/A1:2001 and EN 55011: 1998/A1:1999, Class B supports testing information demonstrating safety and effectiveness of the Cybird LED Curing Light in the intended environment of use.

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

Discussion of Clinical Tests Performed: 7.

No clinical testing was conducted.

8. Conclusions:

The Cybird 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2004

DXM Company, LTD C/O Ms. Carolann Kotula MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K042703

Trade/Device Names: Cybrid LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 29, 2004 Received: September 30, 2004

Dear Ms. Kotula:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewsay as wellermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce tass succed in also encreated of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nat ( 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 mercers, manier are as as a set include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your de free is olassinonal controls. Existing major regulations affecting your device can be may of subject to ston adon Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 -- Ms. Carolann Kotula

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issualice of a substition requirements of the Act of the Act of
that FDA has made a determination that your device complies. You must comply wit that FDA has made a delermination that your device real seencies. You must comply with any Federal statures and regulations administered by one stration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration and l all the Act's requirements, including, but not inner interests as set forth in the quality
labeling (21 CFR Part 801); good manufacturing the class assessments radiation labeling (21 CFR Part 801), good manazetane provincelle, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QS) regulation (2) -542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your avines of your device of your device to a legally premarket notification. The IDA inding of substantal video and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s the promotion of the 110 mm 110 mm Microsoft on the promotions on the pro If you desire specific advice for your device on on for any a for questions on the promotion
contact the Office of Compliance at (301) 594-4613. Additions (1201) 504-4639 - A contact the Office of Compliance at (301) 591-1619 - 1019 - 1010 (301) 594-4639. Also,
and advertising of your device, please contact the Office of Compliance at (31CFR and advertising of your device, prease corract in by reference to premarket notification water the Ast m please note the regulation entities, "Misoralianing of responsibilities under the Act may
Part 807.97) you may obtain. Other general information on your responsibilities at Part 807,97) you may obtain. Other general infecturers, International and Consumer Assistance at its be obtained from the DFTB-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

SusaRunse

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Exhibit B

Indications for Use

510(k) Number (if known): KO 4 2703

Device Name: Cybird LED Curing Light

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Susan Pearson

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