510(k) · Cleared
Recalled · Class II · 2015Lava Ultimate Cad/Cam Restorative for Cerec Lava Ultimate Cad/Cam Restorative for E4D Lava Ultimate Implant Crown Restor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EBF Material, Tooth Shade, Resin
Cleared on Sep 12, 2012 as substantially equivalent to K110131 (3M Espe Dental Products, 2011) and 1 other predicate after a 20-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.
- Decided
- Sep 12, 2012
- Review
- 20 days
- Class
- Class II
- Product code
- EBF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920425 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK920425 3M Brand Restorative Z1003M Company · 1992
- 1 generation backK110131 Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate…3M Espe Dental Products · 2011 · Recalled
- This deviceK122569 Lava Ultimate Cad/Cam Restorative for Cerec Lava Ultimate Cad/Cam…3M Company · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920425 | 3M Brand Restorative Z100 | 3M Company | 1992 | — |
| −1 | K110131 | Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown… | 3M Espe Dental Products | 2011 | 1 |
| 0 (this device) | K122569 | Lava Ultimate Cad/Cam Restorative for Cerec Lava Ultimate Cad/Cam Restorative… | 3M Company | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K110131 | Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown RestorativeSummary page 3…provided in this 5 10(k) submission shows that the product is substantially equivalent to the 3M ESPE's predicate device Lava Ultimate (K1 101311) and to Ivoclar Vivadent AG's IPS emax Press (K982616). This 510(k) submission includes data from in-vitro tes… | 2011 |
| * | K982616 | Ips Empress 2Summary page 2…Code: EBF) Predicate Devices: 3M ESPE's Lava Ultimate CAD/CAM Restorative (Ki 1013 1) Ivoclar Vivadent AG's IPS emax Press (K9826 16) Description of Device: The product is a strong, wear-resistant and highly esthetic mill block t… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 18.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 4 other devices also cite its predicate K110131.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Lava Ultimate restorative is indicated for inlays, onlays, veneers, full crown restorations, including implant supported crowns, permanent three unit bridges in the anterior region and permanent three unit bridges in the premolar region up to the second premolar as the terminal abutment. The bridge consists of two full crown abutments supporting a pontic between them; the two abutments may be either two teeth or two implants.
Lava Ultimate restorative is not indicated for uses other than those listed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122569: Lava Ultimate Cad/Cam Restorative for Cerec Lava Ultimate Cad/Cam Restorative for E4D Lava Ultimate Implant Crown Restor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122569
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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