# K121282: Microlux/DL Microlux/Blu Bio/Screen

- Pathway: 510(k) (Traditional)
- Applicant: Addent, Inc.
- Decided: Jul 24, 2012 after 85 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc: The Microlux DIL (K041614), Microlux BLU (K072309), and Blo/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

Source page: https://510kreport.com/device/K121282
Methodology: https://510kreport.com/methodology