510(k) · Cleared
ClearedLuma Light 2000 Cure Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumalite, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Aug 31, 1999 as substantially equivalent to K962376 (Kreativ, Inc., 1997) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 31, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K952333 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK952333 Plasma Arc Curing SystemAmerican Dental Technologies, Inc. · 1995
- This deviceK992102 Luma Light 2000 Cure LightLumalite, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952333 | Plasma Arc Curing System | American Dental Technologies, Inc. | 1995 | — |
| 0 (this device) | K992102 | Luma Light 2000 Cure Light | Lumalite, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 EBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K962376 | Kreativ Kuring Light SystemSummary page 1…rehand Luma Lite, Inc. 477 Marina Pkwy #400 Chula Vista, CA 91910 (619) 318-1251 Device Name: Luma Light 2000 Cure Light Predicate Devices: Kuring and Bleaching Light K962376 Kreativ, Inc. ) Apollo 95E K981948 DMD Pac Light K952333 American Dental Technologies. Device and indications for use: The Luma… | 1997 |
| * | K981948 | Apollo 95ESummary page 1…kwy #400 Chula Vista, CA 91910 (619) 318-1251 Device Name: Luma Light 2000 Cure Light Predicate Devices: Kuring and Bleaching Light K962376 Kreativ, Inc. ) Apollo 95E K981948 DMD Pac Light K952333 American Dental Technologies. Device and indications for use: The Luma Light 2000 Cure Light is a high int… | 1998 |
| * | K952333 | Plasma Arc Curing SystemSummary page 1…CA 91910 (619) 318-1251 Device Name: Luma Light 2000 Cure Light Predicate Devices: Kuring and Bleaching Light K962376 Kreativ, Inc. ) Apollo 95E K981948 DMD Pac Light K952333 American Dental Technologies. Device and indications for use: The Luma Light 2000 Cure Light is a high intensity filtered light… | 1995 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental composites or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992102 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992102: Luma Light 2000 Cure Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992102
Report an extraction error
Are you the manufacturer?
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