(12 days)
Not Found
No
The description focuses on the device's function as a light curing source with specific wavelengths and power densities, and mentions standard electrical and safety testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.
No
The device is described as an Ultraviolet Activator for polymerization, intended to polymerize dental materials, with no mention of treating disease or health conditions.
No
The device is intended to polymerize dental materials using light, which is a therapeutic function, not diagnostic. It does not identify, assess, or monitor a disease or condition.
No
The device description explicitly states it is a "universal photo-polymerization light curing source working in cordless conditions and producing visible blue light" and mentions a "light-guide," indicating it is a hardware device that emits light. The performance studies also reference hardware-related standards (EN 60601-1, EN 60601-1-2, etc.).
Based on the provided information, the Cybird LED Curing Light is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for polymerizing dental materials in the mouth (restorative composite materials, orthodontic brackets, bonding and sealing materials). This is a direct application to the patient's body.
- Device Description: The description reinforces its use in a clinical setting for photo-polymerization of materials applied to teeth.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Cybird LED Curing Light does not perform any such function.
The device is classified as an "Ultraviolet Activator for polymerization" (21 C.f.r. 872.6070), which is a classification for dental devices used in direct patient care.
N/A
Intended Use / Indications for Use
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.
Product codes
EBZ
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.
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
Not Found
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 Tests: 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. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
Clinical Tests: No clinical testing was conducted.
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
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.
1
Predicate Device Information: 3.
Mini L.E.D by SATELEC (K032465)
Description and Intended Use: 4.
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.
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.
2
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.
3
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.
4
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
5
Exhibit B
Indications for Use
510(k) Number (if known): KO 4 2703
Device Name: Cybird LED Curing Light
Indications For Use:
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.
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:_