510(k) · Cleared
ClearedBio-Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Addent, Inc. · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Jan 23, 2009 as substantially equivalent to K060920 (Led Medical Diagnostics, Inc., 2006) after a 133-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 23, 2009
- Review
- 133 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003995 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060920 | VelscopeSummary page 1…ice The Velscope made by LED Electronics, uses blue light and the principle of biofluorescence for screening and visualization of abnormal oral mucosa Velscope 510(k) No K060920 Comparison to other predicate devices is shown on page 10… | 2006 |
| * | — | Vizilite Named without a submission number | |
| * | — | Microlux/DL Named without a submission number | |
| * | — | Microlux/Blu Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K060920.
How does its category compare?
All NXV devicesNXV Diagnostic Light, Soft Tissue Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NXV
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NXV
95in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXV
No recall names NXV since 2007.
Adverse event reports per year · NXV
1in 2018
MAUDE reports naming product code NXV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 95 | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082668 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082668: Bio-Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082668
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026