# K040635: Carrara Interaction Ceramic System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Mar 30, 2004 after 20 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 K981000 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981000: Carrara Porcelain and Carrara Vincent Porcelain, European Dental Imports, Inc. (1998) Summary page 1.

## Most influential descendants
- K070019: Carrara Volumia (2007), 0 descendants of its own

## Indications for use
The CARRARA INTERACTION CERAMIC SYSTEM is indicated for veneering of metal-ceramic or full ceramic restorative systems.

Source page: https://510kreport.com/device/K040635
Methodology: https://510kreport.com/methodology