(35 days)
Not Found
No
The description focuses on the light curing technology, power density, and operational modes, with no mention of AI or ML capabilities.
No.
The device is described as an Ultraviolet Activator for polymerization, intended to polymerize dental materials, not to treat a disease or condition in a patient.
No
The device is intended to polymerize dental materials, which is a treatment function, not a diagnostic one. It uses light to cure materials, an active intervention, rather than observing or measuring to identify a condition.
No
The device description explicitly details hardware components like an LED light source, light guide, and cordless operation, indicating it is a physical device, not software-only.
Based on the provided information, the Skylight LED Curing Light is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to polymerize dental materials in the mouth (or on materials that will be placed in the mouth). This is a direct treatment or procedure on a patient.
- Device Description: The description focuses on the physical characteristics of the light and its function in hardening dental materials. It doesn't mention any analysis of biological samples or substances outside the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Skylight LED Curing Light does none of these things.
The device is clearly described as a tool used by a practitioner for a dental procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Skylight 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 440-490 nm waveband of visible light.
Product codes
EBZ
Device Description
Skylight by DMETEC 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 Skylight is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490 nm waveband of spectrum with a power density comprised 1,000W/cm2, 13-11mm light q uide.
These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing.
The exposure time can be set by one second to 99 seconds with 3 modes of operation: Standard, Pulse, and Soft Start. It has also memory storage functions for 5 exposure programs set by the practitioner.
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
Non-Clinical Tests: Testing was conducted in accordance with EN 60601-1: 1990 +A, +B; EN 60601-1-2:2001; EN 61000-3-2:2000 and EN 61000-3-3, 1998/A1;2001 and EN 55011: 1995/A1: 1999; Class B supports testing information demonstrating safety and effectiveness of the Skylight 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
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
Koslist |
EXHIBIT #1
510(K) SUMMARY
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.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Dmetec Co., Ltd 402-803 Tchno-Park, 193 Yakdae-dong, Wonmi-ku, Bucheon City, 420-734 Korea Tel: +82-32-234-1441 Fax: +82-32-234-1444 Web site: www.dmetec.com Contact: J.W. Park
Date Summary Prepared: June 13, 2005
2. Name of the Device:
Skylight LED Curing Light
3. Common or Usual Name:
Polymerization Light-Curing Device
4. Predicate Device Information:
Mini L.E.D by SATELEC (K032465)
5. Device Description:
Skylight by DMETEC 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 Skylight is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490 nm waveband of spectrum with a power density comprised 1,000W/cif, 13-11mm light quide.
1
These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing.
The exposure time can be set by one second to 99 seconds with 3 modes of operation: Standard, Pulse, and Soft Start. It has also memory storage functions for 5 exposure programs set by the practitioner.
6. Intended Use:
The Skylight 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 440-490 nm waveband of visible light.
Comparison to Predicate Devices: Mini L.E.D by SATELEC: 7.
The DMETEC Skylight L.E.D curing light has similar design and performance characteristics and identical intended use of the 510(K) cleared light curing unit, the SATELEC Mini L.E.D (K032465) for the photo-polymerization of dental materials of restorative composite, bonding and sealing.
These devices are well established and determined to be safe and effective.
Discussion of Non-Clinical Tests Performed for Determination of 8. Substantial Equivalence are as follows:
Testing was conducted in accordance with EN 60601-1: 1990 +A, +B; EN 60601-1-2:2001; EN 61000-3-2:2000 and EN 61000-3-3, 1998/A1;2001 and EN 55011: 1995/A1: 1999; Class B supports testing information demonstrating safety and effectiveness of the Skylight 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.
Discussion of Clinical Tests Performed: ல்
No clinical testing was conducted
10. Conclusions:
The Skylight LED curing light is substantially similar to the predicate intended use, operation, safety and function, and is effective for its' intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2005
DMETEC Company, Ltd. C/O Ms. Carolann Kotula Official Correspondent MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K051571
Trade/Device Name: Skylight LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 13, 2005 Received: June 14, 2005
Dear Ms. Kotula:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 510(x) premance is substantially equivalent (for the indications for referenced above and have decemined the devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicate ante devices that use stated in the enclosure) to legally manufacture Amendments, or to devices that prov to May 28, 1970, the chaoinent add of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMA). You may have been reclassified in accordance with are provisation (PMA). You may,
Act (Act) that do not require approval of a premarket application of the general Act (Act) that do not require approval or a premail controls provisions of the Act. The general
therefore, market the device, subject to the general controls provisions of d therefore, market the ucvice, subject to are general sease, and adultarstien controls provisions of the nechade requibitions against misbranding and adulteration.
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) mo Existing major regulations affecting your device can be may be subject to such adultions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Feasurerning your device in the Federal Register.
3
Page 2 -- Ms. Carolann Kotula
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s Issualled of a saterial complies with other requirements of the Act or that FDA has made a decemination administered by other Federal agencies. You must comply with any Federal Statules and regulations administration of to: registration and listing (21 CFR Part 807); all the Act sTequirements, incruding, pat novine requirements as set forth in the quality labeling (21 CFR Part 801), good managers and if applicable, the electronic product radiation systems (QD) rogations 531-542 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 anow you to organization of substantial equivalence of your device to a legally premarket noutication: The PDF mailie of basification for your device 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 If you desire specific davice 10- your (240) 276-0115. Also, please note the regulation entitled, Contact the Office of Comphance at (210) 21 CFR Part 807.97). You may obtain other IMISURATION on your responsibilities under the Act from the Division of Small general information on your cosponsionner Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
Enclosure
4
Exhibit B
Page __ 1 __ of ___ 1
ﻨﻘﺴﺘﺎﺕ: ««
510(k) Number (if known): K051571
Device Name: Skylight LED curing light
Indications For Use:
The Skylight LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, materials, rooter and sealing materials that are photo-polymerized in the 440-490nm waveband of visible light.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801 Subpart D) Over-The Counter
(21 CFR 807 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| RsBetz DOS for Dr. Susan Runner | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices |
510(k) Number:_KO51571