# K980597: Carrara PDF, Carrara H, Carrara R

- Pathway: 510(k) (Traditional)
- Applicant: European Dental Imports, Inc.
- Decided: Mar 9, 1998 after 20 days
- Product code: EJT (Alloy, Gold-Based Noble Metal)
- Device class: 2
- Regulation: 21 CFR 872.3060
- Recalls of this device: none
- 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.

## Indications for use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, posts, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Carrara 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/K980597
Methodology: https://510kreport.com/methodology