510(k) · Cleared
ClearedTemporis, Irix Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dws S.R.L. · EBF Material, Tooth Shade, Resin
Cleared on Apr 25, 2024 as substantially equivalent to K202846 (Graphy, Inc., 2021) after a 370-day review. Its family tree reaches back 8 generations to 2004.
- Decided
- Apr 25, 2024
- Review
- 370 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K042819 (2004). 15 ancestors in all, the oldest K920425 (1992). No later device cites it as a predicate yet.
- 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 backK202846 Tera HarzGraphy, Inc. · 2021
- This deviceK231142 Temporis, Irix PlusDws S.R.L. · 2024
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 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| 0 (this device) | K231142 | Temporis, Irix Plus | Dws S.R.L. | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K202846 | Tera HarzSummary page 5…PREDICATE DEVICES: DWS identified the following legally marketed device as substantially equivalent: TERA HARZ, Graphy Inc., K202846 DEVICE DESCRIPTION: Temporis and Irix Plus are methacrylate-based resins used to manufacture… | 2021 |
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 20 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 4 other devices also cite its predicate K202846.
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?
Temporis and Irix Plus are light-curing 3D-printing materials intended for fabricating indirect restorative for both anterior and posterior restorations, such as inlays, onlays, veneers, anterior or posterior crowns and bridges.
Temporis is used for fabricating temporary dental restorations, Irix Plus is used for fabricating permanent dental restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231142: Temporis, Irix Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231142
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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