(27 days)
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No
The summary describes a light-curing device for dental materials and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended to polymerize dental materials, which is a therapeutic intervention.
No
The device is described as polymerizing (setting) dental materials, which is a therapeutic or restorative function, not a diagnostic one.
No
The intended use describes a device that polymerizes dental materials by transmitting light through a rod, which is a hardware function.
Based on the provided information, the Jetlite 5000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by transmission of light through a rod." This describes a device used directly on a patient's teeth for a therapeutic or restorative purpose.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The description of the Jetlite 5000 does not involve any such specimen analysis.
Therefore, the Jetlite 5000 is a dental device used for light curing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Jetlite 5000 is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by transmission of light through a rod.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a wavy line, possibly representing water or a horizon. Encircling the bird is text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 288 2005
Mr. Howard Rowe Consultant J. Morita USA, Incorporated 9 Mason Irvine, California 92618
Re: K051780
Trade/Device Name: Jetlite 5000 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 23, 2005 Received: July 01, 2005
Dear Mr. Rowe:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Howard Rowe
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syettie Y. Michie Oms
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
2
Indications For Use Statement
| 510(k) Number (if known): | Not Assigned to date K051780 |
|---|---|
| --------------------------- | ----------------------------------------- |
Device Name:
Jetlite 5000
Indications For Use:
The Jetlite 5000 is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by transmission of light through a rod. .
(PLEASE DO NOT WRITE BELIOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K051780 |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | ---------------------------------------- | ---- | ---------------------- |