# K993136: Jel Bios 10 (Code Name RD-1801)

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Oct 21, 1999 after 31 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
High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the rharket. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.

Source page: https://510kreport.com/device/K993136
Methodology: https://510kreport.com/methodology