# K033434: Bestaloy

- Pathway: 510(k) (Traditional)
- Applicant: We Dong Myung Dental Industrial Co., Ltd.
- Decided: Nov 12, 2003 after 15 days
- Product code: EJJ (Alloy, Amalgam)
- Device class: 2
- Regulation: 21 CFR 872.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902249 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902249: Luxalloy 50 (Powder, Tablets, Predosed Capsules), Degussa AG (1990) Summary page 1.

## Indications for use
This is a dental amalgam for the filling of tooth cavities of Black’s Classes I and II

Source page: https://510kreport.com/device/K033434
Methodology: https://510kreport.com/methodology