510(k) · Cleared
ClearedCURA-Temp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mgnewton, Ltd. · EBG Crown And Bridge, Temporary, Resin
Cleared on Dec 21, 2022 as substantially equivalent to K073296 (3M Espe AG Dental Products, 2008) after an 812-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Dec 21, 2022
- Review
- 812 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902115 (1990). 22 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 4 generations backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- 3 generations backK991220 Vitron HEspe Dental AG · 1999
- 2 generations backK992645 SinfonyEspe Dental AG · 1999
- 1 generation backK073296 TEMPXN283M Espe AG Dental Products · 2008
- This deviceK202965 CURA-TempMgnewton, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −4 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| −3 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| −2 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| −1 | K073296 | TEMPXN28 | 3M Espe AG Dental Products | 2008 | — |
| 0 (this device) | K202965 | CURA-Temp | Mgnewton, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K073296 | TEMPXN28Summary page 4…-. Regulatory Class : II -. Product Code : EBG 4. Primary Predicate Device -. Trade Name : TempXN28 (currently marketed as Protemp Plus) -. 510(k) Number : K073296 -. Regulation Number : 21 CFR 872.3770 -. Regulation Name : Temporary crown and bridge resin -. Regulatory Class : II… | 2008 |
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 32 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- None of the 22 ancestors has a recall.
- 3 other devices also cite its predicate K073296.
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. 2022, 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?
Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Fabrication of long-lasting temporary restorations.
Lining material for prefabricated temporary crowns made of composite and metal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202965: CURA-Temp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202965
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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