# K123169: Oralid

- Pathway: 510(k) (Traditional)
- Applicant: Forward Science, LLC
- Decided: Mar 13, 2013 after 155 days
- Product code: NXV (Diagnostic Light, Soft Tissue Detector)
- Device class: 2
- Regulation: 21 CFR 872.6350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003995 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101140: Dentlight Oral Exam Light Kit, Dentlight, Inc. (2010) Summary page 2.
- K102083: Velscope VX, Led Dental, Inc. (2010) Summary page 1.

## Indications for use
OraIID is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.

Source page: https://510kreport.com/device/K123169
Methodology: https://510kreport.com/methodology