# K063321: D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138

- Pathway: 510(k) (Traditional)
- Applicant: Neks Technologies, Inc.
- Decided: Mar 30, 2007 after 148 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: 3 generations back to DEN980003 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991098: Difoti System, Electro-Optical Sciences, Inc. (1999) Summary page 1.
- K050019: IN Exam Intraoral Dental X-Ray System, Kavo America (2005) Summary page 1.
- K043156: D-Carie, Model N121-M1, Neks Technologies, Inc. (2005) Summary page 1.
- K023367: Detectar, Model N123-MI, Neks Technologies (2003) Summary page 1.
- (no number) Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems—preamendment, various manufacturers: named in the summary without a submission number
- (no number) Other dental X-ray systems from various manufacturers: named in the summary without a submission number
- (no number) Dental explorer for clinical examination, various manufacturers: named in the summary without a submission number

## Indications for use
Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.

Source page: https://510kreport.com/device/K063321
Methodology: https://510kreport.com/methodology