# K993152: Jel Bios 18 (Code Name RD- 1214)

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Oct 21, 1999 after 30 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
Jel Bios 18 is a high Platinum contaiping Gold base ceramic alloy for porcelain to metal restorations. It has light yellow color and due to high Platinum content this alloy offers excellent thermal stability. It is suitable for long span bridges. It is compatible with most of the porcelains available in the market. It can be used for full crown and also for porcelain to metal restoration of single and three to four crown bridges.

Source page: https://510kreport.com/device/K993152
Methodology: https://510kreport.com/methodology