510(k) · Cleared
ClearedVarseoSmile Crown plus
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 Jun 23, 2020 as substantially equivalent to K162537 (Prismatik Dentalcraft, Inc., 2016) after a 4-day review. Its family tree reaches back 6 generations to 2004. 24 later devices descend from it.
- Decided
- Jun 23, 2020
- Review
- 4 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042819 (2004). 13 ancestors in all, the oldest K920425 (1992). 24 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 5 generations backK091388 GCUC-505GC America, Inc. · 2009
- 4 generations backK123631 MFP-051GC America, Inc. · 2013
- 3 generations backK133824 CerasmartGC America, Inc. · 2014
- 2 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 1 generation backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- This deviceK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- Descendant · cites it directly · 13 of its ownK202846 Tera HarzGraphy, Inc. · 2021
- Descendant · cites it directly · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
- Descendant · 2 generations on · 6 of its ownK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- Descendant · 2 generations on · 4 of its ownK222623 Digital CrownSprintray, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK233596 VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K202846Tera HarzGraphy, Inc. · 2021 · cites it directly13descendants
- K210977E-Dent 1000Envisiontec GmbH · 2021 · cites it directly7descendants
- K213343Saremco Print CROWNTECSaremco Dental AG · 2022 · 2 generations on6descendants
- K222623Digital CrownSprintray, Inc. · 2022 · 2 generations on4descendants
- K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −5 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −4 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −3 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −2 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −1 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| 0 (this device) | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| +1 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| +1 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| +2 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022 | — |
| +2 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| +3 | K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162537 | CAD/CAMouflage Milling BlockSummary page 4…and design principles to the following Predicate device. 510(k) Predicate Device Name Company Name K162537 CAD/CAMouflage Milling Block Prismatik Dentalcraft, Inc. 510(k) Refer… | 2016 |
| † | K143033 | Dentca Denture Base | 2015 |
| † | K992645 | Sinfony | 1999 |
| † | K193553 | VarseoSmile Temp | 2020 |
What descends from it? (24)
See all 244 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 16 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K202846 (Graphy, Inc., 2021) has gone furthest, with 13 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Crown P is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown P material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201668: VarseoSmile Crown plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201668
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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