(47 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The intended use and device description (though not found) point towards a simple light-based device.
No
The device is used for polymerization of dental materials and tooth whitening, which are cosmetic or procedural functions, not therapeutic in nature.
No
The intended use is for polymerization of dental materials and tooth whitening, which are treatment functions, not diagnostic ones.
No
The intended use describes a device that uses high-intensity light for polymerization and tooth whitening, which inherently requires a hardware component to generate and deliver the light. The lack of a device description further supports that this summary is not for a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "High Intensity light for polymerization of dental materials and tooth whitening." This describes a device used directly on the patient (or on materials applied to the patient) for a therapeutic or procedural purpose.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
The function of this device is to cure dental materials and whiten teeth, which are procedures performed in vivo (on the living body) or on materials that will be used in vivo. It does not involve testing samples outside the body.
N/A
Intended Use / Indications for Use
High Intensity light for polymerization of dental materials and tooth whitening.
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
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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 shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1999
Ms. Serene O'Malley Spring Health Products, Incorporated 705 General Washington Avenue Suite 701 Norristown, Pennsylvania 19403
Re: K992728 Spring PowerLite 2000 Trade Name: Regulatory Class: II Product Code: EBZ August 23, 1999 Dated: Received: Auqust 27, 1999
Dear Ms. O'Malley:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 regulations affecting your device can be found in the Code of Eederal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 -Ms. O'Malley
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda,gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ਾ (
к992728 510(k) NUMBER (IF KNOWN):
DEVICE NAME: POwerLite 2000 ________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
High Intensity light for polymerization of dental materials and tooth whitening.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER I IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE
- .
Prescription Use y (Per 21 CFR 801.109) ાર
Over-The-Counter-(Optional Forma
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number .