# K260918: Zolid Lunaris

- Pathway: 510(k) (Traditional)
- Applicant: Amann Girrbach AG
- Decided: Jun 29, 2026 after 102 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: 4 generations back to K980986 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171876: Ceramill Zolid HT+ white, Amann Girrbach AG (2017) Summary page 5.

## Indications for use
Zolid Lunaris is a zirconia ceramic CAD/CAM blank (type I, class 5 according to ISO 6872) for manufacturing fixed dental prostheses to restore tooth anatomy, physiology and aesthetics in (partially) edentulous patients.

Source page: https://510kreport.com/device/K260918
Methodology: https://510kreport.com/methodology