510(k) · Cleared
ClearedMidas Restore
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Apr 15, 2026 as substantially equivalent to K222623 (Sprintray, Inc., 2022) after a 44-day review. Its family tree reaches back 9 generations to 2004.
- Decided
- Apr 15, 2026
- Review
- 44 days
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K042819 (2004). 31 ancestors in all, the oldest K901789 (1990). No later device cites it as a predicate yet.
- 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 deviceK260661 Midas RestoreSprintray, 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 deviceK260661 Midas RestoreSprintray, Inc. · 2026
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) | 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 |
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 this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…n Regulatory Class: Class II Product Code: EBF Secondar Product Code: ELM Predicate Devices Digital Crown (K222623) Device Description SprintRay Midas Restore is a photo-polymer methacrylate resin material used in conjunction with… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 31 ancestors has a recall of any class.
- 2 other devices also cite its predicate K222623.
What is it indicated for?
Midas Restore is a light-curable polymerizable resin intended to be used for the fabrication of individual and fixed definitive full single crowns; definitive partial crowns (e.g., inlays, onlays) in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full 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/K260661 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260661: Midas Restore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260661
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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