# K992895: Impregum F

- Pathway: 510(k) (Special)
- Applicant: Espe Dental AG
- Decided: Sep 8, 1999 after 12 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
Longest line of descent: 1 generation back to K853529 (1986). 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)
- K853529: Impregum-F, Espe GmbH (Us) (1986) Summary page 1.

## Indications for use
Dental impression material for: Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant impressions

Source page: https://510kreport.com/device/K992895
Methodology: https://510kreport.com/methodology