# K043156: D-Carie, Model N121-M1

- Pathway: 510(k) (Traditional)
- Applicant: Neks Technologies, Inc.
- Decided: Apr 28, 2005 after 164 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023367: Detectar, Model N123-MI, Neks Technologies (2003) Summary page 1.
- 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.
- (no number) Dental explorers: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K973638: N.I.T., Inc. Needle Guiding Template, Avid N.I.T., Inc. (1997). Our reading of the summary gave K973638, FDA’s number for N.I.T., Inc. Needle Guiding Template (Avid N.I.T., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alpha 4 LS Automated Microtiterplate Processor”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K063321: D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138 (2007), 0 descendants of its own

## Indications for use
D-Carie is indicated for aiding in the diagnosis of dental carries

Source page: https://510kreport.com/device/K043156
Methodology: https://510kreport.com/methodology