510(k) · Cleared
Recalled · Class II · 2015Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative
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 Jan 21, 2011 as substantially equivalent to K920425 (3M Company, 1992) and 1 other predicate after a 3-day review. Its family tree reaches back 1 generation to 1992. 39 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2011
- Review
- 3 days
- Class
- Class II
- Product code
- EBF
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K920425 (1992). 2 ancestors in all. 39 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK920425 3M Brand Restorative Z1003M Company · 1992
- This deviceK110131 Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate…3M Espe Dental Products · 2011
- Descendant · cites it directly · 32 of its ownK133824 CerasmartGC America, Inc. · 2014
- Descendant · 2 generations on · 26 of its ownK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 3 generations on · 25 of its ownK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 4 generations on · 24 of its ownK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- Descendant · 5 generations on · 13 of its ownK202846 Tera HarzGraphy, Inc. · 2021
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K133824CerasmartGC America, Inc. · 2014 · cites it directly32descendants
- K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016 · 2 generations on26descendants
- K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016 · 3 generations on25descendants
- K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020 · 4 generations on24descendants
- K202846Tera HarzGraphy, Inc. · 2021 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920425 | 3M Brand Restorative Z100 | 3M Company | 1992 | — |
| 0 (this device) | K110131 | Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown… | 3M Espe Dental Products | 2011 | — |
| +1 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| +2 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| +3 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| +4 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| +5 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K920425 | 3M Brand Restorative Z100Summary page 2…(21 CFR 872.3690, Product Code: EBF) Predicate Devices: 3MTM ESPETM ParadigmTM MZlO00 blocks (K920425) 3MTM ESPETM FiltekTM Supreme Ultra Universal Restorative (K08361 0) 3MTM ESPETMI FiltekTM Supr… | 1992 |
| * | K083610 | Filtek Supreme Ultra Universal RestorativeSummary page 2…Predicate Devices: 3MTM ESPETM ParadigmTM MZlO00 blocks (K920425) 3MTM ESPETM FiltekTM Supreme Ultra Universal Restorative (K08361 0) 3MTM ESPETMI FiltekTM Supreme Plus (KO01078 1) Description of Device: The p… | 2008 |
| Kept off the family tree | K001078 | FDA’s K001078 is Sulzer Orthopedics MS-30 Femoral Stem Our reading of the summary gave K001078, FDA’s number for Sulzer Orthopedics MS-30 Femoral Stem (Sulzer Orthopedics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “3M ESPE Filtek Supreme Plus”. Kept off the family tree. | 2000 |
What descends from it? (39)
See all 395 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2015 | Class II | Z-2052-2015 | Device Design | 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers. |
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. 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?
The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110131
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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