(29 days)
No
The summary describes a modification to an existing device by adding a periodontal probe, and there is no mention of AI, ML, image processing, or training/test sets typically associated with AI/ML technologies.
No
The device is strictly for detection and localization of subgingival dental calculus. It does not provide any treatment.
Yes
The device is described as an aid in "detection" and "localization" of subgingival dental calculus, which are diagnostic functions. The name "DIAGNOdent" also suggests a diagnostic purpose.
No
The device description explicitly states it is a modification of existing hardware devices (DIAGNOdent® 2095 with periodontal probe and Diagnodent Pen) and involves adding a periodontal probe, indicating it is a hardware device with potential software components, not 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 "For use as an aid in the detection and localization of subgingival dental calculus." This describes a diagnostic procedure performed in vivo (on a living patient), not in vitro (on samples outside the body).
- Device Description: The device is a modification of existing dental diagnostic tools (DIAGNOdent® 2095 and Diagnodent Pen) used for examining teeth and gums.
- Anatomical Site: The anatomical site is "Subgingival dental calculus," which is located within the mouth of a patient.
- Care Setting: The intended user and care setting are "Dentists' offices," where patient examinations and procedures are performed.
IVD devices typically involve testing biological samples (like blood, urine, tissue) in a laboratory setting to diagnose diseases or conditions. This device is used directly on the patient's teeth and gums.
N/A
Intended Use / Indications for Use
For use as an aid in the detection and localization of subgingival dental calculus.
Product codes
NTK
Device Description
This submission is for a modification of a device system cleared under K042394, the DIAGNOdent® 2095 with periodontal probe, and Diagnodent Pen, K051909. The modification is in the form of adding a periodontal probe to the Diagnodent Pen product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subgingival dental calculus
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
bench, in-vitro, and clinical studies, as well as EMC and electrical safety testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0600080
FEB 8 2006
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 December 26, 2005
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- Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® 2190 with periodontal probe Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes NTK Common/Usual Name: Laser fluorescence caries detection device
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- Indications for Use (intended use): For use as an aid in the detection and localization of subgingival dental calculus.
Image /page/0/Figure/7 description: The image shows two different DIAGNOdent periodontal probes. The first probe is the DIAGNOdent 2095 Periodontal Probe (K042394), and the second probe is the DIAGNOdent 2190 Periodontal Probe. Both probes have two parts labeled as "Part 1" and "Part 2".
1
p.2 KD60080
| Comparison Areas | DIAGNOdent® 2095
With periodontal probe, K042394 | DIAGNOdent® 2190
With periodontal probe |
|---------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Indications for use | For use as an aid in the detection and localization of subgingival dental calculus. | SAME |
| Probe technology | Fiber Optic with sapphire tip. | Probe is integrated into the body of the hand held unit, with sapphire tip. |
| Construction | Base unit with fiber optic detachable probes | Hand held unit with detachable probe tips |
| Light Source | 655 nm