# K121359: Ips 99 One and Ips 99 Ceram

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Jul 27, 2012 after 81 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K141887: Obsidian Press (All Ceramic and Pom) (2014), 2 descendants of its own
- K262239: Obsidian® Press Over Zirconia (2026), 0 descendants of its own
- K160102: Amber Mill Series and Amber Press Series (2016), 0 descendants of its own
- K152103: IPS Style Ceram, IPS Style Ceram One, IPS Style Press (2016), 0 descendants of its own
- K151894: IPS Ivocolor (2015), 0 descendants of its own

## Indications for use
IPS 89 One is a one-layer venaering ceramic for the fabrication of metal-ceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 109K (26-500°C) IPS €8 Ceram Is a conventicnal muli-layer veneering ceramic for the fabrication of metal-&eggflc restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10%K 00°C). IPS 89 Is Intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns.

Source page: https://510kreport.com/device/K121359
Methodology: https://510kreport.com/methodology