510(k) · Cleared
ClearedSapphire O/E Oral Examination System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den-Mat Holdings, LLC · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Apr 3, 2008 after a 114-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 3, 2008
- Review
- 114 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK073483 Sapphire O/E Oral Examination SystemDen-Mat Holdings, LLC · 2008
- Descendant · cites it directly · 5 of its ownK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK253461 Demi ProMeta Systems Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK243921 LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101140Dentlight Oral Exam Light KitDentlight, Inc. · 2010 · cites it directly5descendants
- K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021 · 2 generations on3descendants
- K220471VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022 · 3 generations on2descendants
- K253461Demi ProMeta Systems Co., Ltd. · 2025 · 4 generations on0descendants
- K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073483 | Sapphire O/E Oral Examination System | Den-Mat Holdings, LLC | 2008 | — |
| +1 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| +2 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| +3 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
| +4 | K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025 | — |
| +4 | K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101140 | Dentlight Oral Exam Light Kit | 2010 | 5 |
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?
- Of its descendants, K101140 (Dentlight, Inc., 2010) has gone furthest, with 5 descendants of its own.
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. 2008, 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 Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional bral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K073483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073483: Sapphire O/E Oral Examination System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073483
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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