(47 days)
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No
The 510(k) summary describes a dental curing light, a device that uses illumination for curing materials and tooth whitening. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No.
The primary function of the device is illumination for curing and whitening, not treating a disease or condition directly.
No
The device is used for curing dental restorative materials and tooth whitening, which are treatment or procedure-related functions, not diagnostic.
No
The intended use describes a "source of illumination," which strongly suggests a hardware component (a light source) is the primary functional element of the device. There is no mention of software being the sole or primary component.
Based on the provided information, the Flipo Curing Light is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for curing dental restorative materials and tooth whitening. These are procedures performed directly on the patient's teeth, not on samples taken from the body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples (blood, urine, tissue, etc.) or the diagnosis of diseases or conditions based on such analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Flipo Curing Light's function is purely therapeutic/procedural, not diagnostic.
N/A
Intended Use / Indications for Use
"The Flipo 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
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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
dentistry
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design, with flowing lines representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Mr. Hillard W. Welch U.S. Representative for LOKKI (France) 344 Annabelle Point Road 02632-2402 Centerville, MA
Re : K994028 Flipo Curing Light Trade Name: Requlatory Class: II Product Code: EBZ Dated: November 22, 1999 Received: November 26, 1999
Dear Mr. Welch:
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, Drug, 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, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਖੇ 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
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Page 2 - Mr. Welch
obligation you might have under sections 531 through 542 of 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) 594-4692. 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
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
510(k) Number (if known): K994028
"Flipo" Curing Light Device Name: __
Indications For Use:
"The Flipo 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)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801,109) |
510(k) Number
Susan Kinne (Division Sign-Off) Division of Dental, Infection Control, and General Hospital D
99 41838
OR
Over-The-Counter Use
Optional Formal 1-2-96)