510(k) · Cleared
ClearedBluephase 16I
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 Sep 20, 2005 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Sep 20, 2005
- Review
- 81 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK051782 Bluephase 16IIvoclar Vivadent, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK140432 HI-Light, HI-Light PlusDentall Corporation · 2015
- Descendant · 2 generations on · 3 of its ownK170529 Delight, Delight ortho, B&Lite SDentall Co., Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK253461 Demi ProMeta Systems Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK192233 LED Curing LightFoshan Cicada Dental Instrument Co, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK192009 LED Curing LightEzgo Group, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K140432HI-Light, HI-Light PlusDentall Corporation · 2015 · cites it directly4descendants
- K170529Delight, Delight ortho, B&Lite SDentall Co., Ltd. · 2017 · 2 generations on3descendants
- K253461Demi ProMeta Systems Co., Ltd. · 2025 · 3 generations on0descendants
- K192233LED Curing LightFoshan Cicada Dental Instrument Co, Ltd. · 2020 · 3 generations on0descendants
- K192009LED Curing LightEzgo Group, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051782 | Bluephase 16I | Ivoclar Vivadent, Inc. | 2005 | — |
| +1 | K140432 | HI-Light, HI-Light Plus | Dentall Corporation | 2015 | — |
| +2 | K170529 | Delight, Delight ortho, B&Lite S | Dentall Co., Ltd. | 2017 | — |
| +3 | K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025 | — |
| +3 | K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | 2020 | — |
| +3 | K192009 | LED Curing Light | Ezgo Group, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140432 | HI-Light, HI-Light Plus | 2015 | 4 |
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, K140432 (Dentall Corporation, 2015) has gone furthest, with 4 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.
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 curing polymerization of dental composites, luting materials, cements and other light cured materials.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051782: Bluephase 16I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051782
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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