# K974704: Hydrogum

- Pathway: 510(k) (Traditional)
- Applicant: Zhermack S.P.A.
- Decided: Jan 29, 1998 after 44 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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
Hydrogum is an alginate dental impression material that is intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth.

Source page: https://510kreport.com/device/K974704
Methodology: https://510kreport.com/methodology