# K973548: Mercury Dental

- Pathway: 510(k) (Traditional)
- Applicant: Aleaciones Dentales Zeyco, S.A. DE C.V.
- Decided: Mar 23, 1998 after 186 days
- Product code: ELY (Mercury)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K093587: Dental Mercury (2010), 0 descendants of its own

## Indications for use
IS USED TO MIX WITH A SILVER-TIN-COPPER POWDER ALLOY TO MAKE A DENTAL AMALGAM AND THEN TO FILL DENTAL CAVITIES

Source page: https://510kreport.com/device/K973548
Methodology: https://510kreport.com/methodology