510(k) · Cleared
ClearedTEMPXN28
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · EBG Crown And Bridge, Temporary, Resin
Cleared on Jan 9, 2008 as substantially equivalent to K033022 (3M Espe AG Dental Products, 2003) and 2 other predicates after a 47-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it.
- Decided
- Jan 9, 2008
- Review
- 47 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902115 (1990). 21 ancestors in all, the oldest K833757 (1984). 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 3 generations backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- 2 generations backK991220 Vitron HEspe Dental AG · 1999
- 1 generation backK992645 SinfonyEspe Dental AG · 1999
- This deviceK073296 TEMPXN283M Espe AG Dental Products · 2008
- Descendant · cites it directly · 0 of its ownK202965 CURA-TempMgnewton, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK151144 SuPro 1003M Deutschland GmbH · 2015
- Descendant · cites it directly · 0 of its ownK141562 MSN-006GC America, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK122039 Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08…Kettenbach GmbH & Co. KG · 2012
Most influential descendants
Showing 4 of 4 · See all- K202965CURA-TempMgnewton, Ltd. · 2022 · cites it directly0descendants
- K151144SuPro 1003M Deutschland GmbH · 2015 · cites it directly0descendants
- K141562MSN-006GC America, Inc. · 2014 · cites it directly0descendants
- K122039Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BKettenbach GmbH & Co. KG · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −3 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| −2 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| −1 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| 0 (this device) | K073296 | TEMPXN28 | 3M Espe AG Dental Products | 2008 | — |
| +1 | K202965 | CURA-Temp | Mgnewton, Ltd. | 2022 | — |
| +1 | K151144 | SuPro 100 | 3M Deutschland GmbH | 2015 | — |
| +1 | K141562 | MSN-006 | GC America, Inc. | 2014 | — |
| +1 | K122039 | Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross B | Kettenbach GmbH & Co. KG | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K033022 | Protemp 3 GarantSummary page 1…and Bridge Material Predicate Device Protemp TM 3 Garant"M by 3M ESPE .........................K033022 Luxatemp Fluorescence by DMG USA, Inc .............. K013674 Sinfony by 3M ESPE .......… | 2003 |
| * | K013674 | Luxatemp/Luxatemp Solar/InstatempSummary page 1…Device Protemp TM 3 Garant"M by 3M ESPE .........................K033022 Luxatemp Fluorescence by DMG USA, Inc .............. K013674 Sinfony by 3M ESPE ................................................. K992645 Traditional 510(k) TempXN28… | 2002 |
| * | K992645 | SinfonySummary page 1…Luxatemp Fluorescence by DMG USA, Inc .............. K013674 Sinfony by 3M ESPE ................................................. K992645 Traditional 510(k) TempXN28… | 1999 |
What descends from it? (4)
4 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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K202965 (Mgnewton, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K033022.
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. 2008, 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/K073296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073296: TEMPXN28.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073296
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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