# K093587: Dental Mercury

- Pathway: 510(k) (Traditional)
- Applicant: Dmg USA, Inc.
- Decided: Jan 21, 2010 after 63 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
Longest line of descent: 1 generation back to K973548 (1998). 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)
- K973548: Mercury Dental, Aleaciones Dentales Zeyco, S.A. DE C.V. (1998) Summary page 1.

## Indications for use
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.

Source page: https://510kreport.com/device/K093587
Methodology: https://510kreport.com/methodology