510(k) · Cleared
ClearedOralid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forward Science, LLC · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Mar 13, 2013 as substantially equivalent to K101140 (Dentlight, Inc., 2010) and 1 other predicate after a 155-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Mar 13, 2013
- Review
- 155 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003995 (2001). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 5 generations backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- 4 generations backK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- 3 generations backK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- 2 generations backK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- 1 generation backK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- This deviceK123169 OralidForward Science, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −5 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| −4 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| −3 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| −2 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| −1 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| 0 (this device) | K123169 | Oralid | Forward Science, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K101140 | Dentlight Oral Exam Light KitSummary page 2…mal tissue appears dark due to lack of fluorescence. Substantial Equivalence OraIIDTM has the same intended use and technical characteristics as the predicate devices (K 10 1140 and K 102083); each uses fluorescenice as the primary miode to aid in Visualization of tissue for determining oral tissue abnorma… | 2010 |
| * | K102083 | Velscope VXSummary page 1…DentLight Inc 1411 E. Campbell Rd, Suite 500 Richardson, TX 75081 VELscope Vx (K 102083) LED Medical Diagnostics 235 - 5589 Byrne Road B… | 2010 |
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 12 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K101140.
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. 2013, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123169: Oralid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123169
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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