510(k) · Cleared
ClearedDentlight Oral Exam Light Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentlight, Inc. · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Jul 15, 2010 as substantially equivalent to K070523 (Led Dental, Inc., 2007) and 2 other predicates after an 84-day review. Its family tree reaches back 5 generations to 2001. 5 later devices descend from it.
- Decided
- Jul 15, 2010
- Review
- 84 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K003995 (2001). 9 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 4 generations backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- 3 generations backK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- 2 generations backK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- 1 generation backK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- This deviceK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK253461 Demi ProMeta Systems Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK243921 LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK123169 OralidForward Science, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021 · cites it directly3descendants
- K220471VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022 · 2 generations on2descendants
- K253461Demi ProMeta Systems Co., Ltd. · 2025 · 3 generations on0descendants
- K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025 · 3 generations on0descendants
- K123169OralidForward Science, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −4 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| −3 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| −2 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| −1 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| 0 (this device) | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| +1 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| +2 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
| +3 | K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025 | — |
| +3 | K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K070523 | Modification to: VelscopeSummary page 1…tary Name: Dentlight Oral Exam Light Kit Comnmon/Usual Name: Oral Examination Light Classification Name: Ultraviolet Detector (872.6350) 3. PREDICATE DEVICES Veiscope (K070523) by LED Medical Diagnostics Sapphire OlE Oral Examination System by Den-Mat Holdings (K073483) Identafi 3000 (K090 135) by Trimir… | 2007 |
| * | K073483 | Sapphire O/E Oral Examination SystemSummary page 1…tion Name: Ultraviolet Detector (872.6350) 3. PREDICATE DEVICES Veiscope (K070523) by LED Medical Diagnostics Sapphire OlE Oral Examination System by Den-Mat Holdings (K073483) Identafi 3000 (K090 135) by Trimira, Remicalm 4. DEVICE DESCRIPTION Dentlight Oral Exam Light Kit is a rechargeable-battery-po… | 2008 |
| * | K090135 | Trimira Identafi 3000Summary page 1…etector (872.6350) 3. PREDICATE DEVICES Veiscope (K070523) by LED Medical Diagnostics Sapphire OlE Oral Examination System by Den-Mat Holdings (K073483) Identafi 3000 (K090 135) by Trimira, Remicalm 4. DEVICE DESCRIPTION Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit desig… | 2009 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K210550 (Ultradent Products, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K070523.
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. 2010, 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?
Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101140: Dentlight Oral Exam Light Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101140
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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