510(k) · Cleared
ClearedVarseoSmile TriniQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · EBF Material, Tooth Shade, Resin
Cleared on Nov 9, 2023 as substantially equivalent to K213343 (Saremco Dental AG, 2022) after a 1-day review. Its family tree reaches back 9 generations to 2004. 3 later devices descend from it.
- Decided
- Nov 9, 2023
- Review
- 1 day
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K042819 (2004). 17 ancestors in all, the oldest K920425 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 5 generations between
- 3 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 2 generations backK202846 Tera HarzGraphy, Inc. · 2021
- 1 generation backK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- This deviceK233596 VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023
- Descendant · cites it directly · 1 of its ownK253053 Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261356 Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250497 Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 8 generations backK091388 GCUC-505GC America, Inc. · 2009
- 7 generations backK123631 MFP-051GC America, Inc. · 2013
- 6 generations backK133824 CerasmartGC America, Inc. · 2014
- 5 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 4 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 3 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 2 generations backK202846 Tera HarzGraphy, Inc. · 2021
- 1 generation backK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- This deviceK233596 VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023
Most influential descendants
Showing 3 of 3 · See all- K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025 · cites it directly1descendant
- K261356Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K250497Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −8 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −7 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −6 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −5 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −4 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −3 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| −2 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| −1 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022 | — |
| 0 (this device) | K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023 | — |
| +1 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025 | — |
| +2 | K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026 | — |
| +1 | K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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.
What descends from it? (3)
2 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 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K253053 (Hangzhou SHINING3D Dental Technology Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K213343.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
VarseoSmile TriniQ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233596 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233596: VarseoSmile TriniQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233596
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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