510(k) · Cleared
ClearedProtemp H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · EBG Crown And Bridge, Temporary, Resin
Cleared on Aug 10, 2000 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 76 later devices descend from it.
- Decided
- Aug 10, 2000
- Review
- 7 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
76 later devices descend from it, 4 citing it directly.
- This deviceK002364 Protemp HEspe Dental AG · 2000
- Descendant · cites it directly · 63 of its ownK020256 Unicem3M Espe AG Dental Products · 2002
- Descendant · cites it directly · 46 of its ownK033022 Protemp 3 Garant3M Espe AG Dental Products · 2003
- Descendant · 2 generations on · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- Descendant · 2 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 3 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K020256Unicem3M Espe AG Dental Products · 2002 · cites it directly63descendants
- K033022Protemp 3 Garant3M Espe AG Dental Products · 2003 · cites it directly46descendants
- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · 2 generations on37descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002364 | Protemp H | Espe Dental AG | 2000 | — |
| +1 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| +1 | K033022 | Protemp 3 Garant | 3M Espe AG Dental Products | 2003 | — |
| +2 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (76)
See all 764 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, K020256 (3M Espe AG Dental Products, 2002) has gone furthest, with 63 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.
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 | — |
https://510kreport.com/device/K002364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002364: Protemp H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002364
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026