(29 days)
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No
The summary describes a dental curing light, which is a simple illumination device. There are no mentions of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is used for curing dental materials, which is a functional process rather than a direct treatment or diagnosis of a medical condition.
No
Explanation: The device is described as a "Source of illumination for curing visible light cured dental materials." This function is therapeutic/restorative (curing materials), not diagnostic (identifying or characterizing disease).
No
The intended use describes a device that provides illumination for curing dental materials, which inherently requires a hardware component (a light source). The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Source of illumination for curing visible light cured dental materials such as composites, bonding agents, and cements." This describes a device used directly on a patient's dental materials to facilitate a physical process (curing).
- Lack of IVD Characteristics: IVDs are devices used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any of these activities.
Therefore, this device falls under the category of a dental device used for treatment, not an IVD used for diagnostic purposes.
N/A
Intended Use / Indications for Use
Source of illumination for curing visible light cured dental materials such as composites and glass ionomer cements.
Product codes
EBZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of three birds in flight.
AUG - 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry L. Joritz Director of Requlatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re : K012134 Trade/Device Name: GC E-Light Requlation Number: 872.6070 Regulatory Class: II Product Code: EBZ Dated: July 6, 2001 Received: July 9, 2001
Dear Mr. Joritz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action.
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Page 2- Mr. Joritz
concerning your device in the Federal Register. Please note: concerning your device in and ification submission does this response to your premaint have under sections 531 not arrect any obligation for devices under the Electronic Chrough 542 Of the Act 101 xevisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as mis lecter wour 510 (k) premarket notification. The FDA described in your sio\n privalence of your device to a legally I inding of substancial equivaler of classification for your marketed predicate device robated to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpcorrer additionally 809.10 for in regulacion (21 crk raros), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) 3941, Jertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibion on its toll-free number Incernational and combined - 6597 or at its internet address (000) : //www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO12134
510(k) Number (if known): Ko 12 12 12 12 4
Device Name: GC e-Light_______________________________________________________________________________________________________________________________________________________
Indications For Use:
Source of illumination for curing visible light cured dental materials such Source of firmination for caring views in one cements.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devig 510(k) Number .