# K971574: Jelbond-PDF

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: May 20, 1997 after 43 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. The FDA summary names no predicate by number.

## Indications for use
It is a gold/platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure. It is suitable for longspans and bridges. It is a high noble alloy and the high gold content makes it compatible with most porcelains in the market. Jelbond-PdF blend well with tissue and enhances the esthetic qualities of the finished restoration.

Source page: https://510kreport.com/device/K971574
Methodology: https://510kreport.com/methodology