510(k) · Cleared
ClearedPower Led
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Products of USA, Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Feb 27, 2004 after a 94-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 27, 2004
- Review
- 94 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (1)
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 |
|---|---|---|---|
| * | — | EliparFreeLight Named without a submission number |
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.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The intended use of Power LED is to act as a polymerization source using visible light
to cure composite resins.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033697 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033697: Power Led.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033697
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026