# K122569: Lava Ultimate Cad/Cam Restorative for Cerec Lava Ultimate Cad/Cam Restorative for E4D Lava Ultimate Implant Crown Restor

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Sep 12, 2012 after 20 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: 2 generations back to K920425 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative, 3M Espe Dental Products (2011) Summary page 3.
- K982616: Ips Empress 2, Ivoclar North America, Inc. (1998) Summary page 2.

## 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
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.

Source page: https://510kreport.com/device/K122569
Methodology: https://510kreport.com/methodology