# K123402: Diagnocam

- Pathway: 510(k) (Traditional)
- Applicant: Kaltenbach & Voigt GmbH
- Decided: Sep 24, 2013 after 323 days
- Product code: NTK (Light Transmission Caries Detector)
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933455 (1994). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043068: Difoti Usb 2.0 System, Electro-Optical Sciences, Inc. (2004) Summary page 1.
- K071429: TI2200 Transillumination Cable, Kerr Corporation (2007) Summary page 1.

## Most influential descendants
- K172007: CamX Triton HD Proxi Head (2017), 4 descendants of its own
- K193659: iTero Element 5D (2020), 2 descendants of its own
- K240573: iTero Lumina™ Pro (2024), 1 descendant of its own
- K182712: DEXIS CariVu 3-in-1 by KaVo (2019), 1 descendant of its own
- K261847: iTero Lumina™ Pro (2026), 0 descendants of its own

## Indications for use
The DIAGNOcam 2170 is a diagnostic aid for the detection of open or incipient caries lesions above the gingiva and for monitoring the progress of such lesions. Indications: * Detection of smooth surface caries * Detection of occlusal caries * Detection of proximal caries * Detection of initial caries * Detection of secondary caries * Detection of cracks

Source page: https://510kreport.com/device/K123402
Methodology: https://510kreport.com/methodology