# K082668: Bio-Screen

- Pathway: 510(k) (Traditional)
- Applicant: Addent, Inc.
- Decided: Jan 23, 2009 after 133 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: 2 generations back to K003995 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060920: Velscope, Led Medical Diagnostics, Inc. (2006) Summary page 1.
- (no number) Vizilite: named in the summary without a submission number
- (no number) Microlux/DL: named in the summary without a submission number
- (no number) Microlux/Blu: named in the summary without a submission number

## Indications for use
The Bio-Screen is intended to be used by a dentist or health care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities and aid in defining lesion borders

Source page: https://510kreport.com/device/K082668
Methodology: https://510kreport.com/methodology