510(k) · Cleared
ClearedFiltek Bulk Fill Posterior Restroative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe Dental Products · EBF Material, Tooth Shade, Resin
Cleared on May 8, 2014 as substantially equivalent to K083610 (3M Company, 2008) and 2 other predicates after a 13-day review. Its family tree reaches back 1 generation to 2008. 9 later devices descend from it.
- Decided
- May 8, 2014
- Review
- 13 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K083610 (2008). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK083610 Filtek Supreme Ultra Universal Restorative3M Company · 2008
- This deviceK141081 Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014
- Descendant · cites it directly · 5 of its ownK183476 3M Filtek Universal Restorative3M Espe Dental Products · 2019
- Descendant · 2 generations on · 1 of its ownK241147 Any-ComMediclus Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK191306 Llis, Vittra APSDentscare Ltda · 2019
- Descendant · cites it directly · 1 of its ownK163207 Filtek One Bulk Fill Restorative3M Company · 2016
- Descendant · 3 generations on · 0 of its ownK250823 Any-Com FlowMediclus Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K1834763M Filtek Universal Restorative3M Espe Dental Products · 2019 · cites it directly5descendants
- K241147Any-ComMediclus Co., Ltd. · 2024 · 2 generations on1descendant
- K191306Llis, Vittra APSDentscare Ltda · 2019 · 2 generations on1descendant
- K163207Filtek One Bulk Fill Restorative3M Company · 2016 · cites it directly1descendant
- K250823Any-Com FlowMediclus Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083610 | Filtek Supreme Ultra Universal Restorative | 3M Company | 2008 | — |
| 0 (this device) | K141081 | Filtek Bulk Fill Posterior Restroative | 3M Espe Dental Products | 2014 | — |
| +1 | K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | 2019 | — |
| +2 | K241147 | Any-Com | Mediclus Co., Ltd. | 2024 | — |
| +2 | K191306 | Llis, Vittra APS | Dentscare Ltda | 2019 | — |
| +1 | K163207 | Filtek One Bulk Fill Restorative | 3M Company | 2016 | — |
| +3 | K250823 | Any-Com Flow | Mediclus Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K083610 | Filtek Supreme Ultra Universal RestorativeSummary page 1…Product Code: EBF Predicate Devices: FiltekTM Supreme Ultra Universal Restorative (K083610) Metamorphosis (K09 1023) Trade name: SonicFill, Sonic-Activated Bulk Fill Composite… | 2008 |
| * | K091023 | MetamorphosisSummary page 1…Product Code: EBF Predicate Devices: FiltekTM Supreme Ultra Universal Restorative (K083610) Metamorphosis (K09 1023) Trade name: SonicFill, Sonic-Activated Bulk Fill Composite Tetric EvoCeram Bulk Fill (KI 1… | 2009 |
| * | K111958 | Tetric Evoceram Bulk FillSummary page 1…Metamorphosis (K09 1023) Trade name: SonicFill, Sonic-Activated Bulk Fill Composite Tetric EvoCeram Bulk Fill (KI 111958) FiltekTM Bulk Fill Posterior Restorative 510(k) Page 27 of 260 3M ESPE Descr… | 2011 |
What descends from it? (9)
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?
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Direct anterior and posterior restorations (including occlusal surfaces)
Base/liner under direct restorations
Core build-ups
Splinting
Restorations of deciduous teeth
Extended fissure sealing in molars and premolars
Repair of defects in porcelain restorations, enamel, and temporaries
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/K141081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141081: Filtek Bulk Fill Posterior Restroative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141081
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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