510(k) · Cleared
ClearedVita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vita · EBG Crown And Bridge, Temporary, Resin
Cleared on Jun 1, 2007 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.
- Decided
- Jun 1, 2007
- Review
- 53 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 3 citing it directly.
- This deviceK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- Descendant · cites it directly · 12 of its ownK102776 Extra-Oral, Additive Computer Aided Manufacture and Curing SystemDeltamed GmbH · 2011
- Descendant · cites it directly · 9 of its ownK080182 Zeno Pmma DiscWieland Dental + Technik GmbH & Co. KG · 2008
- Descendant · 2 generations on · 6 of its ownK122025 Brightglass Brightglass MKtk Medical Supplies GmbH · 2012
- Descendant · 2 generations on · 4 of its ownK180657 Resin for Temporary Crown & BridgeDentis Co., Ltd. · 2018
- Descendant · 2 generations on · 4 of its ownK131664 Copra Temp Pmma-DiskWhite Peaks Dental Systems GmbH & Co. KG · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K102776Extra-Oral, Additive Computer Aided Manufacture and Curing SystemDeltamed GmbH · 2011 · cites it directly12descendants
- K080182Zeno Pmma DiscWieland Dental + Technik GmbH & Co. KG · 2008 · cites it directly9descendants
- K122025Brightglass Brightglass MKtk Medical Supplies GmbH · 2012 · 2 generations on6descendants
- K180657Resin for Temporary Crown & BridgeDentis Co., Ltd. · 2018 · 2 generations on4descendants
- K131664Copra Temp Pmma-DiskWhite Peaks Dental Systems GmbH & Co. KG · 2013 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| +1 | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | Deltamed GmbH | 2011 | — |
| +1 | K080182 | Zeno Pmma Disc | Wieland Dental + Technik GmbH & Co. KG | 2008 | — |
| +2 | K122025 | Brightglass Brightglass M | Ktk Medical Supplies GmbH | 2012 | — |
| +2 | K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | 2018 | — |
| +2 | K131664 | Copra Temp Pmma-Disk | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (23)
See all 233 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?
- Of its descendants, K102776 (Deltamed GmbH, 2011) has gone furthest, with 12 descendants of its own.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
CAD-Temp is used for the fabrication of multi-unit, full or partial anatomical long term temporary bridge restorations with up to 2 pontics using the inLab or CEREC systems of Sirona. The bridge block can also be used for temporary crowns. The Vita CAD-Temp acrylic polymer blocs are available in the four shades OMIT, 2M2T, 3M2T, and 4M2T and in the size CT-40 (15.5 x 19 x 39 mm).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K070991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070991: Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070991
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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