# K022430: Iso Functional

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 18, 2002 after 85 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K110378: Impression Compound (2011), 1 descendant of its own
- K213175: No Stress Impress (2023), 0 descendants of its own

## Indications for use
ISO Functional is used as a rebasing and relining impression material.

Source page: https://510kreport.com/device/K022430
Methodology: https://510kreport.com/methodology