K Number
K051909
Device Name
DIAGNODENT
Manufacturer
Date Cleared
2005-10-21

(99 days)

Product Code
Regulation Number
872.1745
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as an aid in the diagnosis of dental caries.
Device Description
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.
More Information

DIAGNOdent® 2095, K983658

Not Found

No
The summary describes a physical modification (packaging) of a previously cleared device and does not mention any computational or algorithmic changes related to AI/ML.

No
Explanation: The device is intended "for use as an aid in the diagnosis of dental caries," not for treatment or therapy.

Yes
The "Intended Use / Indications for Use" states, "For use as an aid in the diagnosis of dental caries."

No

The device description explicitly states it is a "pen-like device," indicating a physical hardware component, not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "For use as an aid in the diagnosis of dental caries." While diagnosis is mentioned, the key aspect of an IVD is that it performs tests on samples taken from the human body (like blood, urine, tissue, etc.) in vitro (outside the body).
  • Device Description: The description mentions a "pen-like device" used in a dentist's office. This strongly suggests the device is used directly on the patient's teeth rather than analyzing a sample taken from the patient.
  • Anatomical Site: The anatomical site is "Dental," which further supports the idea of direct application to the teeth.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are typical characteristics of IVDs.

The device appears to be a diagnostic tool used in vivo (on the living body) to aid in the diagnosis of dental caries, likely through some form of light or other non-invasive method applied directly to the tooth surface.

N/A

Intended Use / Indications for Use

For use as an aid in the diagnosis of dental caries.

Product codes (comma separated list FDA assigned to the subject device)

NTK, NBL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentists' offices

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)

bench, invitro, and clinical studies, as well as EMC and electrical safety testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

DIAGNOdent® 2095, K983658

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

K051909

0CT 2 1 2005

EXHIBIT 2 510(k) Summary KaVo Dental Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Miller, Director of RA/QA July 11, 2005

    1. Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® 2190 Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes NTK Common/Usual Name: Laser fluorescence caries detection device
    1. Equivalent legally marketed device: DIAGNOdent® 2095, K983658.
    1. Indications for Use (intended use): For use as an aid in the diagnosis of dental caries.
    1. Description of the Device: 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.

Image /page/0/Picture/7 description: The image shows two different DIAGNOdent devices. On the left is the Predicate DIAGNOdent 2095, which has a screen and a probe. On the right is the DIAGNOdent 2190, which is a handheld device with a screen. Both devices are used for dental diagnostics.

1

    1. Safety and Effectiveness, comparison to predicate device:

| Comparison
Areas | DIAGNOdent® 2095,
K983658 | 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