510(k) · Cleared
ClearedPertac-Hybrid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH (Us) · EBF Material, Tooth Shade, Resin
Cleared on Aug 9, 1990 after a 188-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 94 later devices descend from it.
- Decided
- Aug 9, 1990
- Review
- 188 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 2 citing it directly.
- This deviceK900510 Pertac-HybridEspe GmbH (Us) · 1990
- Descendant · cites it directly · 90 of its ownK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- Descendant · 2 generations on · 70 of its ownK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- Descendant · 3 generations on · 63 of its ownK020256 Unicem3M Espe AG Dental Products · 2002
- Descendant · 2 generations on · 59 of its ownK992645 SinfonyEspe Dental AG · 1999
- Descendant · 4 generations on · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K962440Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996 · cites it directly90descendants
- K974458Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998 · 2 generations on70descendants
- K020256Unicem3M Espe AG Dental Products · 2002 · 3 generations on63descendants
- K992645SinfonyEspe Dental AG · 1999 · 2 generations on59descendants
- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · 4 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| +1 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| +2 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| +3 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| +2 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| +4 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 8 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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? (94)
See all 942 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, K962440 (Espe GmbH & Co. Kg., 1996) has gone furthest, with 90 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
https://510kreport.com/device/K900510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K900510: Pertac-Hybrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K900510
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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