510(k) · Cleared
ClearedDigital Crown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sprintray, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Dec 14, 2022 as substantially equivalent to K210977 (Envisiontec GmbH, 2021) after a 105-day review. Its family tree reaches back 8 generations to 2004. 4 later devices descend from it.
- Decided
- Dec 14, 2022
- Review
- 105 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K042819 (2004). 30 ancestors in all, the oldest K901789 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 7 generations backK091388 GCUC-505GC America, Inc. · 2009
- 6 generations backK123631 MFP-051GC America, Inc. · 2013
- 5 generations backK133824 CerasmartGC America, Inc. · 2014
- 4 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 3 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 2 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 1 generation backK210977 E-Dent 1000Envisiontec GmbH · 2021
- This deviceK222623 Digital CrownSprintray, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK242277 Crown HTSprintray, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261246 SRGC-06GC America, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260152 Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT…Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · 2026
- Descendant · cites it directly · 0 of its ownK260661 Midas RestoreSprintray, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K242277Crown HTSprintray, Inc. · 2024 · cites it directly1descendant
- K261246SRGC-06GC America, Inc. · 2026 · 2 generations on0descendants
- K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · 2026 · cites it directly0descendants
- K260661Midas RestoreSprintray, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −7 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −6 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −5 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −4 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −3 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −2 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| −1 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| 0 (this device) | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| +1 | K242277 | Crown HT | Sprintray, Inc. | 2024 | — |
| +2 | K261246 | SRGC-06 | GC America, Inc. | 2026 | — |
| +1 | K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026 | — |
| +1 | K260661 | Midas Restore | Sprintray, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K210977 | E-Dent 1000Summary page 4…ion Number: 21 CFR 872.3690 Product Code: EBF Secondary Product Codes: EBI, ELM Predicate Device: E-Dent 1000 (K210977) (Primary Predicate) Device Description SprintRay Digital Crown resin consists of a curable dental acrylate resin that is… | 2021 |
What descends from it? (4)
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 18 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K242277 (Sprintray, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K210977.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
SprintRay Digital Crown is a light-curable polymerizable resin intended to be used
for the fabrication of; individual and fixed definitive full single crowns; definitive
partial crowns in anterior and posterior area, individual and fixed single veneers;
artificial teeth for dental prostheses, which are used for removable definitive full
dentures; and individual and removable monolithic full and partial dentures in
dental offices and laboratories. The material is an alternative to traditional
restorative dental material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222623: Digital Crown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222623
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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