# K091826: Elegant

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Sep 25, 2009 after 98 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K812116 (1981). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001) Summary page 1.
- K980986: Procad, Ivoclar USA, Inc. (1998) Summary page 1.
- K053438: Glass Ceramics, 3M Espe AG Dental Products (2006) Summary page 1.
- K974231: Position Penta, Position Penta Quick, Espe GmbH & Co. Kg. (1998) Summary page 1.
- K994251: Ketac-Molar Quick, Espe Dental AG (2000) Summary page 1.

## Indications for use
CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine.

Source page: https://510kreport.com/device/K091826
Methodology: https://510kreport.com/methodology