510(k) · Cleared
ClearedPertac II/Pertac II Aplitip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH & Co. Kg. · EBF Material, Tooth Shade, Resin
Cleared on Sep 11, 1996 as substantially equivalent to K900510 (Espe GmbH (Us), 1990) after a 79-day review. Its family tree reaches back 1 generation to 1990. 90 later devices descend from it.
- Decided
- Sep 11, 1996
- Review
- 79 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900510 (1990). 90 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- This deviceK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- Descendant · cites it directly · 70 of its ownK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- Descendant · 2 generations on · 63 of its ownK020256 Unicem3M Espe AG Dental Products · 2002
- Descendant · cites it directly · 59 of its ownK992645 SinfonyEspe Dental AG · 1999
- Descendant · 3 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
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 90 · See all- K974458Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998 · cites it directly70descendants
- K020256Unicem3M Espe AG Dental Products · 2002 · 2 generations on63descendants
- K992645SinfonyEspe Dental AG · 1999 · cites it directly59descendants
- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · 3 generations on37descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| 0 (this device) | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| +1 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| +2 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| +1 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| +3 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 5 | 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), 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 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? (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 |
|---|---|---|---|
| * | K900510 | Pertac-HybridSummary page 1…Y E EFFECTIVE ESPE is submitting‘a 510 (k) premarket notification for modifications to its 510(k) submission for tooth shade resin material, tradenamed Pertac@—HYbrid® (K900510). The modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling mat… | 1990 |
What descends from it? (90)
See all 905 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?
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 | — |
What is it indicated for?
The modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials, and are indicated for the following uses: (1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962440: Pertac II/Pertac II Aplitip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962440
Report an extraction error
Are you the manufacturer?
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