(59 days)
Not Found
Not Found
No
The summary describes a dental light curing device and contains no mention of AI or ML.
Yes
This device is used to cure dental materials, which are used in the treatment of dental conditions. Therefore, it is a therapeutic device.
No
The device is described as being used for the polymerization of light curing dental materials, indicating it is a therapeutic or treatment device rather than one used for diagnosis.
No
The intended use describes the polymerization of light curing dental materials, which inherently requires a hardware component (a light source) to perform the function. The summary does not mention any software functionality related to this process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the polymerization of light curing dental materials. This is a process performed on the patient (or materials being applied to the patient), not on a sample taken from the patient to diagnose a condition.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose, such as analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status.
- Device Description (Not Found): While the device description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections (Not Found): The absence of information in sections like "Anatomical Site," "Indicated Patient Age Range," and "Intended User / Care Setting" further suggests it's a device used in a clinical setting for treatment or procedure, not for laboratory-based diagnosis.
In summary, the device's function is to cure dental materials, which is a therapeutic or procedural action, not a diagnostic one performed on a biological sample.
N/A
Intended Use / Indications for Use
Polymerization of light curing dental materials with photo initiator for the wavelength range 440 – 480 nm.
Suitable for light curing composite restorative materials, anterior composites, posterior composites, bonding agents, pit and fissure sealants, orthodontic adhesive and flowable composites.
Product codes
EBZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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 logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
APR 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 729 North Route 83, Suite 315 Bensenville, Illinois 60106
Re: K030568
Trade/Device Name: Radii Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ Dated: February 20, 2003 Received: February 24, 2003
Dear Ms. Cheetham:
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 – Ms. Samantha J. Cheetham
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 (OS) 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 (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 your 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 Runres
Susan Runner, DDS, MA 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):
Device Name:
Indications For Use:
Radii
Ko30568
Polymerization of light curing dental materials with photo initiator for the wavelength range 440 – 480 nm.
Suitable for light curing composite restorative materials, anterior composites, posterior composites, bonding agents, pit and fissure sealants, orthodontic adhesive and flowable composites.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X | OR | Over-The-Counter Use: | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |||
| Kei Muby for MSM | ||||
| (Division Sign-Off) | ||||
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | ||||
| 510(k) Number: | K030568 |