510(k) · Cleared
ClearedDelight, Delight ortho, B&Lite S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentall Co., Ltd. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Aug 8, 2017 as substantially equivalent to K140432 (Dentall Corporation, 2015) after a 167-day review. Its family tree reaches back 2 generations to 2005. 3 later devices descend from it.
- Decided
- Aug 8, 2017
- Review
- 167 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051782 (2005). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK051782 Bluephase 16IIvoclar Vivadent, Inc. · 2005
- 1 generation backK140432 HI-Light, HI-Light PlusDentall Corporation · 2015
- This deviceK170529 Delight, Delight ortho, B&Lite SDentall Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK253461 Demi ProMeta Systems Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK192233 LED Curing LightFoshan Cicada Dental Instrument Co, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK192009 LED Curing LightEzgo Group, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051782 | Bluephase 16I | Ivoclar Vivadent, Inc. | 2005 | — |
| −1 | K140432 | HI-Light, HI-Light Plus | Dentall Corporation | 2015 | — |
| 0 (this device) | K170529 | Delight, Delight ortho, B&Lite S | Dentall Co., Ltd. | 2017 | — |
| +1 | K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025 | — |
| +1 | K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | 2020 | — |
| +1 | K192009 | LED Curing Light | Ezgo Group, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K140432 | HI-Light, HI-Light PlusSummary page 5…Name: Ultraviolet activator for polymerization Product Code: EBZ Classification regulation: 21CFR 872.6070 4. Predicate Device Hi-Light, Hi-Light plus (K140432) by DENTALL Co., Ltd. 5. Device Description Delight, Delight ortho and B&Lite S are light-emitting diode (LED) type dental cu… | 2015 |
What descends from it? (3)
3 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253461 (Meta Systems Co., Ltd., 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. 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?
For light curing polymerization of dental composites, luting materials, cements and other light cured materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170529: Delight, Delight ortho, B&Lite S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170529
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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