(99 days)
For use as an aid in the diagnosis of dental caries.
This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.
The provided 510(k) summary for the KaVo DIAGNOdent® 2190 does not contain specific acceptance criteria or a detailed study report proving the device meets acceptance criteria. The document states that the conclusion of substantial equivalence is "based on indications for use, bench, invitro, and clinical studies, as well as EMC and electrical safety testing," but it does not provide the details of these studies or the performance metrics used.
Therefore, I cannot fulfill your request for detailed information on acceptance criteria, sample sizes, expert qualifications, or specific study designs as this information is not present in the provided text.
Based solely on the provided text, the following information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
Not provided in the document. The document lists a comparison of general characteristics between the predicate (DIAGNOdent® 2095) and the new device (DIAGNOdent® 2190), indicating that for most aspects, the new device is "SAME" or has minor modifications (e.g., integrated probe, slightly different laser power, LCD numbers instead of LED numbers).
| Comparison Areas | Predicate (DIAGNOdent® 2095) | DIAGNOdent® 2190 |
|---|---|---|
| Indications for use | For use as an aid in the Diagnosis of Dental Caries | SAME |
| Probe technology | Fiber Optic with sapphire tip. | Probe is integrated into the body of the hand held unit, with sapphire tip. |
| Light Source | 655 nm |
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.