# K981244: BW-1 (Code Name RD-0807)

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Aug 13, 1998 after 129 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
BW-1 ( Code Name : RD-0807 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application and compatible with low fusing porcelains in the market. It can also be used as Type-III crown and bridge alloy. BW-1 is copper and palladium free, rich yellow color alloy and it provides quality restoration. It polishes to a high luster and is suitable for Single and 3 to 4 crowns.

Source page: https://510kreport.com/device/K981244
Methodology: https://510kreport.com/methodology