510(k) · Cleared
ClearedTetric Evoceram Bulk Fill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Oct 14, 2011 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Oct 14, 2011
- Review
- 95 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 4 citing it directly.
- This deviceK111958 Tetric Evoceram Bulk FillIvoclar Vivadent, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK141081 Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014
- Descendant · 2 generations on · 5 of its ownK183476 3M Filtek Universal Restorative3M Espe Dental Products · 2019
- Descendant · cites it directly · 2 of its ownK183380 Tetric PowerFillIvoclar Vivadent, AG · 2019
- Descendant · 3 generations on · 1 of its ownK241147 Any-ComMediclus Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK191306 Llis, Vittra APSDentscare Ltda · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K141081Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014 · cites it directly9descendants
- K1834763M Filtek Universal Restorative3M Espe Dental Products · 2019 · 2 generations on5descendants
- K183380Tetric PowerFillIvoclar Vivadent, AG · 2019 · cites it directly2descendants
- K241147Any-ComMediclus Co., Ltd. · 2024 · 3 generations on1descendant
- K191306Llis, Vittra APSDentscare Ltda · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111958 | Tetric Evoceram Bulk Fill | Ivoclar Vivadent, Inc. | 2011 | — |
| +1 | K141081 | Filtek Bulk Fill Posterior Restroative | 3M Espe Dental Products | 2014 | — |
| +2 | K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | 2019 | — |
| +1 | K183380 | Tetric PowerFill | Ivoclar Vivadent, AG | 2019 | — |
| +3 | K241147 | Any-Com | Mediclus Co., Ltd. | 2024 | — |
| +3 | K191306 | Llis, Vittra APS | Dentscare Ltda | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 154 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, K141081 (3M Espe Dental Products, 2014) has gone furthest, with 9 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. 2011, this device’s year, is highlighted.
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?
Restoration of Deciduous teeth
Restorations in the posterior region (Classes I and ii)
Class V restorations (cervical caries, root erosion, wedge-shaped defects)
Extended fissure sealing in molars and premnolars
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111958: Tetric Evoceram Bulk Fill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111958
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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