# K211916: IPS e.max One

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Aug 20, 2021 after 60 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 4.

## Indications for use
-Missing tooth structure in anterior and posterior teeth Types of restorations: - Veneers - Inlays - Onlays (e.g. occlusal veneers, partial crowns) - Crowns

Source page: https://510kreport.com/device/K211916
Methodology: https://510kreport.com/methodology