# K981000: Carrara Porcelain and Carrara Vincent Porcelain

- Pathway: 510(k) (Traditional)
- Applicant: European Dental Imports, Inc.
- Decided: May 15, 1998 after 58 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.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040635: Carrara Interaction Ceramic System (2004), 1 descendant of its own
- K070019: Carrara Volumia (2007), 0 descendants of its own

## Indications for use
Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelain-fused-to-metal elements of a fixed or removable dental prosthesis. Carrara Porcelain and Carrara Vincent Porcelain are recommended for use only with Carrara and Cera E dental alloys. After fabrication and finishing, the completed prosthesis is approved and placed in the patient’s mouth by the dentist.

Source page: https://510kreport.com/device/K981000
Methodology: https://510kreport.com/methodology