# K260859: Rosetta SM, Rosetta SP

- Pathway: 510(k) (Traditional)
- Applicant: Hass Corp.
- Decided: Jun 11, 2026 after 87 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: 1 generation back to K051705 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 5.

## Indications for use
Rosetta SM is CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays, and full ceramic 3-unit anterior bridges. Rosetta SP is an all-ceramic system for the creation of occlusal veneers, thin veneers, veneers, inlays, onlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal abutment, and crown, splinted crown or 3-unit bridge up to the second premolar placed on top of an implant abutment.

Source page: https://510kreport.com/device/K260859
Methodology: https://510kreport.com/methodology