510(k) · Cleared
ClearedCuringPen Dental Curing Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Sifary Medical Technology Co., Ltd. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Nov 23, 2022 as substantially equivalent to K200809 (DiaDent Group International, 2020) after a 217-day review. Its family tree reaches back 4 generations to 2009. 1 later device descends from it.
- Decided
- Nov 23, 2022
- Review
- 217 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K091020 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK091020 Bluephase 20IIvoclar Vivadent, Inc. · 2009
- 3 generations backK163613 Bluephase Style 20iIvoclar Vivadent, AG · 2017
- 2 generations backK190272 Bluephase PowerCureIvoclar Vivadent, AG · 2019
- 1 generation backK200809 D-LUX+DiaDent Group International · 2020
- This deviceK221152 CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK253131 Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K091020 | Bluephase 20I | Ivoclar Vivadent, Inc. | 2009 | — |
| −3 | K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | 2017 | — |
| −2 | K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019 | — |
| −1 | K200809 | D-LUX+ | DiaDent Group International | 2020 | — |
| 0 (this device) | K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K200809 | D-LUX+Summary page 4…EBZ Submission type Traditional 510(K) 4. Predicate Device Manufacturer: DiaDent Group International Device name: D-Lux+ 510(K) Number: K200809 5. Device Description The CuringPen Dental Curing Light is designed to polymerize all photo-activated dental materials in the… | 2020 |
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 |
|---|---|---|---|
| K253131 | Curing Light (M-Cure 6) | 2026 | 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253131 (Guangzhou Rebornendo Medical Instrument Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K200809.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The CuringPen Dental Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 380-515nm waveband of visible light.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221152: CuringPen Dental 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/K221152
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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