510(k) · Cleared
ClearedBluephase 20I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Jun 12, 2009 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Jun 12, 2009
- Review
- 64 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK091020 Bluephase 20IIvoclar Vivadent, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK163613 Bluephase Style 20iIvoclar Vivadent, AG · 2017
- Descendant · 2 generations on · 8 of its ownK190272 Bluephase PowerCureIvoclar Vivadent, AG · 2019
- Descendant · 3 generations on · 7 of its ownK200809 D-LUX+DiaDent Group International · 2020
- Descendant · 4 generations on · 2 of its ownK220826 LED Curing LightFoshan Coxo Medical Instrument Co., Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK221152 CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K163613Bluephase Style 20iIvoclar Vivadent, AG · 2017 · cites it directly9descendants
- K190272Bluephase PowerCureIvoclar Vivadent, AG · 2019 · 2 generations on8descendants
- K200809D-LUX+DiaDent Group International · 2020 · 3 generations on7descendants
- K220826LED Curing LightFoshan Coxo Medical Instrument Co., Ltd. · 2022 · 4 generations on2descendants
- K221152CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091020 | Bluephase 20I | Ivoclar Vivadent, Inc. | 2009 | — |
| +1 | K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | 2017 | — |
| +2 | K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019 | — |
| +3 | K200809 | D-LUX+ | DiaDent Group International | 2020 | — |
| +4 | K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
| +4 | K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 112 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?
- Of its descendants, K163613 (Ivoclar Vivadent, AG, 2017) has gone furthest, with 9 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. 2009, 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 the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091020 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091020: Bluephase 20I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091020
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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