# K042394: Diagnodent Perio Tip (Accessory)

- Pathway: 510(k) (Traditional)
- Applicant: Kavo America Corporation
- Decided: Aug 2, 2005 after 334 days
- Product code: NBL (Light-Induced Fluorescence 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: 2 generations back to DEN980003 (1998). 4 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN990002: Kavo Diagnodent, Kavo America (2000). Our reading of the summary gave K983658, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990002, Kavo Diagnodent (Kavo America), granted Feb 22, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K023367: Detectar, Model N123-MI, Neks Technologies (2003) Summary page 1.

## Most influential descendants
- K060080: Diagnodent 2190 with Periodontal Probe (2006), 27 descendants of its own
- K073074: Key Laser Iii 1243 US with Detect (2008), 26 descendants of its own
- K101658: Waterlase MD Turbo Plus Model 7200XXX (2010), 25 descendants of its own
- K161669: Waterlase Express (2016), 21 descendants of its own
- K190319: Waterlase Laser System Family (2019), 19 descendants of its own

## Indications for use
For use as an aid in the detection and localization of subgingival dental calculus.

Source page: https://510kreport.com/device/K042394
Methodology: https://510kreport.com/methodology