510(k) · Cleared
ClearedCrown HT
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 Oct 1, 2024 as substantially equivalent to K222623 (Sprintray, Inc., 2022) after a 61-day review. Its family tree reaches back 9 generations to 2004. 1 later device descends from it.
- Decided
- Oct 1, 2024
- Review
- 61 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K042819 (2004). 31 ancestors in all, the oldest K901789 (1990). 1 later device descends from it, 1 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 backK210977 E-Dent 1000Envisiontec GmbH · 2021
- 1 generation backK222623 Digital CrownSprintray, Inc. · 2022
- This deviceK242277 Crown HTSprintray, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261246 SRGC-06GC America, Inc. · 2026
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 backK210977 E-Dent 1000Envisiontec GmbH · 2021
- 1 generation backK222623 Digital CrownSprintray, Inc. · 2022
- This deviceK242277 Crown HTSprintray, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K261246SRGC-06GC America, Inc. · 2026 · 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 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| −1 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| 0 (this device) | K242277 | Crown HT | Sprintray, Inc. | 2024 | — |
| +1 | K261246 | SRGC-06 | GC America, 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 |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222623 | Digital CrownSummary page 5…ss: Class II Product Code: EBF Secondar Product Code: EBI, ELM Predicate Devices Digital Crown (K222623) Device Description SprintRay Crown HT is a photo-polymer methacrylate resin material used in conjunction with a… | 2022 |
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 |
|---|---|---|---|
| K261246 | SRGC-06 | 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 20 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 31 ancestors has a recall of any class.
- Of its descendants, K261246 (GC America, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K222623.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Crown HT 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/K242277 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242277: Crown HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242277
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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