510(k) · Cleared
ClearedFermit N Light-Curing Temporary Filling Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · EBG Crown And Bridge, Temporary, Resin
Cleared on Dec 10, 1993 after a 52-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 10, 1993
- Review
- 52 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK934978 Fermit N Light-Curing Temporary Filling MaterialIvoclar North America, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK111666 Evadyne Temporary Crown and Bridge ResinNeodental Chemical Products Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK972892 Cavit-LCEspe GmbH & Co. Kg. · 1997
- Descendant · 2 generations on · 0 of its ownK192158 DiaTempDiaDent Group International · 2020
- Descendant · cites it directly · 0 of its ownK052800 Provisional Inlay/Onlay KitDmg USA, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK990982 Cavit LCEspe Dental AG · 1999
Most influential descendants
Showing 5 of 5 · See all- K111666Evadyne Temporary Crown and Bridge ResinNeodental Chemical Products Co., Ltd. · 2011 · cites it directly1descendant
- K972892Cavit-LCEspe GmbH & Co. Kg. · 1997 · cites it directly1descendant
- K192158DiaTempDiaDent Group International · 2020 · 2 generations on0descendants
- K052800Provisional Inlay/Onlay KitDmg USA, Inc. · 2006 · cites it directly0descendants
- K990982Cavit LCEspe Dental AG · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934978 | Fermit N Light-Curing Temporary Filling Material | Ivoclar North America, Inc. | 1993 | — |
| +1 | K111666 | Evadyne Temporary Crown and Bridge Resin | Neodental Chemical Products Co., Ltd. | 2011 | — |
| +1 | K972892 | Cavit-LC | Espe GmbH & Co. Kg. | 1997 | — |
| +2 | K192158 | DiaTemp | DiaDent Group International | 2020 | — |
| +1 | K052800 | Provisional Inlay/Onlay Kit | Dmg USA, Inc. | 2006 | — |
| +2 | K990982 | Cavit LC | Espe Dental AG | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
3 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, K111666 (Neodental Chemical Products Co., Ltd., 2011) has gone furthest, with 1 descendant 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/K934978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934978: Fermit N Light-Curing Temporary Filling Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934978
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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