# K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: Jan 21, 2011 after 3 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920425 (1992). 2 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920425: 3M Brand Restorative Z100, 3M Company (1992) Summary page 2.
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 2.

## Cited in the summary but kept off the family tree
- K001078: Sulzer Orthopedics MS-30 Femoral Stem, Sulzer Orthopedics, Inc. (2000). 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.

## Most influential descendants
- K133824: Cerasmart (2014), 32 descendants of its own
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own
- K201668: VarseoSmile Crown plus (2020), 24 descendants of its own
- K202846: Tera Harz (2021), 13 descendants of its own

## Recalls of this device
- Jun 15, 2015 · Class II · Z-2052-2015: 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.

## Indications for use
The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.

Source page: https://510kreport.com/device/K110131
Methodology: https://510kreport.com/methodology