510(k) · Cleared
ClearedBluephase Style 20i
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Apr 4, 2017 as substantially equivalent to K091020 (Ivoclar Vivadent, Inc., 2009) after a 103-day review. Its family tree reaches back 1 generation to 2009. 9 later devices descend from it.
- Decided
- Apr 4, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091020 (2009). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK091020 Bluephase 20IIvoclar Vivadent, Inc. · 2009
- This deviceK163613 Bluephase Style 20iIvoclar Vivadent, AG · 2017
- Descendant · cites it directly · 8 of its ownK190272 Bluephase PowerCureIvoclar Vivadent, AG · 2019
- Descendant · 2 generations on · 7 of its ownK200809 D-LUX+DiaDent Group International · 2020
- Descendant · 3 generations on · 2 of its ownK220826 LED Curing LightFoshan Coxo Medical Instrument Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK221152 CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK253131 Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K190272Bluephase PowerCureIvoclar Vivadent, AG · 2019 · cites it directly8descendants
- K200809D-LUX+DiaDent Group International · 2020 · 2 generations on7descendants
- K220826LED Curing LightFoshan Coxo Medical Instrument Co., Ltd. · 2022 · 3 generations on2descendants
- K221152CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091020 | Bluephase 20I | Ivoclar Vivadent, Inc. | 2009 | — |
| 0 (this device) | K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | 2017 | — |
| +1 | K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019 | — |
| +2 | K200809 | D-LUX+ | DiaDent Group International | 2020 | — |
| +3 | K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
| +3 | K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022 | — |
| +4 | K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K091020 | Bluephase 20ISummary page 4…cation Name: Activator, Ultraviolet, for Poymerization 872.6070 (Classification Code EBZ) Predicate Device: Bluephase 20i - K091020 Device Description: Bluephase® Style 20i is an LED polymerization light that produces energy-rich blue plight. It is use… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190272 | Bluephase PowerCure | 2019 | 8 |
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?
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
With its "Polywave" broadband spectrum, Bluephase Style 20i is suitable for the polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163613: Bluephase Style 20i.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163613
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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