510(k) · Cleared
ClearedHermes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · EBF Material, Tooth Shade, Resin
Cleared on Feb 24, 2004 as substantially equivalent to K010781 (3M Company, 2001) and 4 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Feb 24, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K843566 (1984). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K843566 | Ketac-Silver | Espe GmbH (Us) | 1984 | — |
| −1 | K960954 | Ketac-Molar Aplicap | Espe GmbH & Co. Kg. | 1996 | — |
| 0 (this device) | K033996 | Hermes | 3M Espe AG Dental Products | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 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? (5)
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 |
|---|---|---|---|
| * | K010781 | 3M Espe HaurSummary page 1…Resin-Based Filling Material Predicate Devices 3M ESPE HAUR by 3M ESPE .................. K 010781 Tetric Ceram by Vivadent .......................... K 964285 AH Plus by Dentsply ..… | 2001 |
| * | K964285 | Tetric CeramSummary page 1…Predicate Devices 3M ESPE HAUR by 3M ESPE .................. K 010781 Tetric Ceram by Vivadent .......................... K 964285 AH Plus by Dentsply ................................. K 960548 Pertac If by ESPE ..… | 1997 |
| * | K960548 | AH Plus Root Canal SealerSummary page 1…K 010781 Tetric Ceram by Vivadent .......................... K 964285 AH Plus by Dentsply ................................. K 960548 Pertac If by ESPE ....................................... K 962440 Ketac Molar by E… | 1996 |
| * | K962440 | Pertac II/Pertac II AplitipSummary page 1…85 AH Plus by Dentsply ................................. K 960548 Pertac If by ESPE ....................................... K 962440 Ketac Molar by ESPE ................................ K 960954 510(k) Hermes… | 1996 |
| * | K960954 | Ketac-Molar AplicapSummary page 1…548 Pertac If by ESPE ....................................... K 962440 Ketac Molar by ESPE ................................ K 960954 510(k) Hermes 4 510(k) Summary of Safety and Effectiveness, page 4 o… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K010781.
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?
Direct anterior restorations including:
Class III, IV, V and VI
Veneers
Incisal edge repair
Direct posterior restorations including:
Class I or II or V
Sandwich technique with glass ionomer resin material
Cusp buildups
Core buildups
Splinting
Indirect anterior and posterior restorations including:
Inlays
Onlays
Veneers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033996 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033996: Hermes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033996
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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