# K053114: Silverfil

- Pathway: 510(k) (Traditional)
- Applicant: Dunia Perwira Manufacturing Sdn. Bhd.
- Decided: Nov 15, 2005 after 8 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
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
Silvertul amalgam is used by dental professionals to fill tooth cavities It is used in the same way as other amalgams used in the world today Its usage and handling techniques are the same as other amalgams

Source page: https://510kreport.com/device/K053114
Methodology: https://510kreport.com/methodology