# K012174: Eris Layering Materials

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Aug 27, 2001 after 46 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 9, 2015 · Class II · Z-2265-2015: Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.

## Indications for use
Eris Layering materials are porcelain powders used in our pressable ceramic system, Empress 2, which is used for metal free single unit, and multiple unit bonded crown and bridge restorations.

Source page: https://510kreport.com/device/K012174
Methodology: https://510kreport.com/methodology