(69 days)
Not Found
Not Found
No
The summary describes a dental curing light, which is a hardware device for illumination. There are no mentions of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is described as a "Plasma Curing Light" specifically for "curing dental restorative materials" and "tooth whitening activities performed in dentistry," which are therapeutic procedures.
No
Explanation: The device is described as a "source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities." These are treatment procedures (curing, whitening), not diagnostic activities (identifying, analyzing, or determining a condition).
No
The device is described as a "Plasma Curing Light," which is a hardware device used for curing dental materials. The description does not indicate it is software only.
Based on the provided information, the RMO Plasma Curing Light is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cure dental restorative materials and for tooth whitening. These are procedures performed directly on the patient's tooth, not on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly points to a device used in a clinical setting for direct patient treatment.
- IVD Definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The RMO Plasma Curing Light does not fit this definition.
Therefore, the RMO Plasma Curing Light is a dental device used for treatment and procedures performed directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RMO Plasma Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.
Product codes
EBZ
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized image of a human figure in profile, repeated three times to create a sense of depth or movement. The figure is abstract and appears to be part of a larger design, possibly representing a bird or other symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2003
Lokki Lasers Medicaux C/O Mr. Hillard W. Welch 344 Annabelle Point Road Centerville, Massachusetts 02632-2402
Re: K024374
Trade/Device Name: RMO Plasma Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Light for Polymerization Regulatory Class: II Product Codes: EBZ Dated: November 12, 2002 Received: December 31, 2002
Dear Mr. Welch:
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 vour 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. Hillard W. Welch
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 vour 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Runoar
Susan Runner, DDS, MÁ Interim 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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510(k) Number (if known):
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The RMO Plasma Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| MEB for MSR | |
|---|---|
| (Division Sign/Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices, | |
| 510(k) Number: | K024374 |
| Prescription Use
| (Per 21 CFR 801.109) ✓ | OR Over-The-Counter Use |
|---|---|
| --------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------- |
(Optional Format 1-2-96)