(84 days)
Not Found
No
The device description and performance studies focus on illumination and visualization properties, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is used for visualization and examination, not for treating a disease or condition. Its intended use is to aid in diagnosis, not therapy.
Yes.
The device is indicated as an "adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions," which implies aiding in the diagnosis of these conditions. The predicate devices listed (Velscope, Sapphire O/E Oral Examination System, Identafi 3000) are also known diagnostic devices used for oral lesion detection.
No
The device description explicitly lists hardware components such as a cordless unit, interchangeable light heads, filters, charging stand, power adapter, and eyewear.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions." This describes a device used in vivo (on a living patient) to assist in visual examination.
- Device Description: The description reinforces this by detailing a "cordless unit designed for illumination and examination for dental and physician's office." It describes a light source and filters used directly on the patient.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to diagnose or monitor a condition. This device does not mention the collection or analysis of any biological specimens.
- Anatomical Site: The anatomical site is the "Oral cavity," which is a part of the living patient.
Therefore, the Dentlight Oral Exam Light Kit is an in vivo diagnostic or examination device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dentlight Oral Exam Light Kit is indicated for providing illumination to aid visualization during oral procedures and an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
Product codes
EAQ, NXV
Device Description
Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit designed for if!umination and examination for dental and physician's office on any procedures which require a small homogenous and well-defined spot and natural tissue reflectance and fluorescence visualization of healthy and abnormal tissue.
Dentlight Oral Exam Light Kit consists of a cordless unit with interchangeable light head (White and Violet), custom adaptable Fluorescence Loupe Filters and Filter Caps, Charging Stand, Power Adapter, and Patient Protective Eyewear Goggle.
Mentions image processing
Illumination and Fluorescence Image
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist and physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted to evaluate the functionality and performance of the proposed Dentlight Oral Exam Light Kit:
- Optical Power Testing .
- Optical wavelength .
- Beam Quality .
- Illumination and Fluorescence Image .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6350 Ultraviolet detector.
(a)
Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.(b)
Classification. Class II.
0
|