510(k) · Cleared
ClearedSmartLite Pro Modular LED Curing Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Nov 20, 2019 as substantially equivalent to K061341 (CAO Group, Inc., 2006) and 1 other predicate after a 131-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Nov 20, 2019
- Review
- 131 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K061341 (2006). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK061341 Palmlight 10, Model 001-00030CAO Group, Inc. · 2006
- This deviceK191865 SmartLite Pro Modular LED Curing LightDentsply Sirona · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061341 | Palmlight 10, Model 001-00030 | CAO Group, Inc. | 2006 | — |
| 0 (this device) | K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 EBZ? 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 EBZ device
- #1 K253131 Curing Light (M-Cure 6)score 12.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K061341 | Palmlight 10, Model 001-00030Summary page 5…Primary Predicate 510(k) Company Name Devices Palmlight 10 K061341 CAO Group, Incorporated Microlux Transilluminator K062961 AdDent, Incorporated… | 2006 |
| * | K062961 | Microlux TransilluminatorSummary page 5…Devices Palmlight 10 K061341 CAO Group, Incorporated Microlux Transilluminator K062961 AdDent, Incorporated Reference Device: Reference Device 510(k)… | 2007 |
| † | K110756 | Bluephase Style | 2011 |
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 2 ancestors has a recall.
- 1 other device also cites its predicate K061341.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EBZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBZ
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBZ
1in 2025
MAUDE reports naming product code EBZ, 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 | 10 | 47 | 0 | 1 |
| 2008 | 5 | 75 | 0 | 7 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 137 | 0 | 18 |
| 2012 | 1 | — | 1 | 20 |
| 2013 | 3 | 171 | 0 | 27 |
| 2014 | 3 | 289 | 0 | 31 |
| 2015 | 4 | 252 | 0 | 8 |
| 2016 | 4 | 251 | 0 | 3 |
| 2017 | 8 | 158 | 0 | 5 |
| 2018 | 2 | — | 1 | 3 |
| 2019 | 5 | 145 | 0 | 0 |
| 2020 | 5 | 164 | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 5 | 144 | 1 | 5 |
| 2023 | 3 | 255 | 0 | 7 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 4 | 105 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For light activated polymerization of dental materials such as composites, luting cements, and sealants using visible light.
For intraoral illumination used upon initial examination of the dental patient and dental transillumination to help locate crown fractures, posterior and anterior caries, and for use as an auxiliary light source for endodontic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191865: SmartLite Pro Modular LED Curing Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191865
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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