# K981257: Jelfine-52 (Code Name RD-0901)

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Aug 13, 1998 after 129 days
- Product code: EJS (Alloy, Other 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
Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko’s “Olympia” and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.

Source page: https://510kreport.com/device/K981257
Methodology: https://510kreport.com/methodology