# K982616: Ips Empress 2

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Sep 8, 1998 after 43 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.
13 later devices descend from it; 4 cite it directly.
0 of 14 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
- K100781: Obsidian Ceramic Blocks (2010), 5 descendants of its own
- K994435: Opc 3G All-Ceramic System, Core and Overlay Porcelains (2000), 5 descendants of its own
- K141400: Dcceram System (2015), 3 descendants of its own
- K141887: Obsidian Press (All Ceramic and Pom) (2014), 2 descendants of its own
- K141788: Obsidian Milling Blocks (2014), 2 descendants of its own

## Indications for use
Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration

Source page: https://510kreport.com/device/K982616
Methodology: https://510kreport.com/methodology