510(k) · Cleared
ClearedPremium Plus C01/C02 LED Curing Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premium Plus International Limited · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Aug 22, 2016 as substantially equivalent to K082408 (Dentmate Technology Co., Ltd., 2008) and 1 other predicate after a 259-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Aug 22, 2016
- Review
- 259 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040551 (2004). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK040551 Coltolux Led Curing LightColtene/Whaledent, Inc. · 2004
- This deviceK153514 Premium Plus C01/C02 LED Curing LightPremium Plus International Limited · 2016
- Descendant · cites it directly · 0 of its ownK250009 LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040551 | Coltolux Led Curing Light | Coltene/Whaledent, Inc. | 2004 | — |
| 0 (this device) | K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | 2016 | — |
| +1 | K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K082408 | Ledex, Model: WL-070Summary page 4…on: Ultraviolet activator for polymerization Product Code: EBZ (A)Primary Predicate Device to Premium Plus C01 LED Curing Light: Trade Name: Ledex WL-070 510(k) Number: K082408 Manufactured by: Dentmate Technology Company, Limited (B) Primary Predicate Device to Premium Plus C02 LED Curing Light: Trade N… | 2008 |
| * | K040551 | Coltolux Led Curing LightSummary page 4…hnology Company, Limited (B) Primary Predicate Device to Premium Plus C02 LED Curing Light: Trade Name: Coltolux○ R LED Curing Light 510(k) Number: K040551 Manufactured by: Coltene/Whaledent Incorporated An electronic copy of the submission is being provided which is an exact duplic… | 2004 |
| † | K110582 | Valo Cordless | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250009 | LED Curing Light (C01-X, C02-X) | 2025 | 0 |
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.
- Of its descendants, K250009 (Premium Plus (Dongguan) Limited, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153514: Premium Plus C01/C02 LED Curing Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153514
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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