# K994192: Impregum Penta M Monosoft

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Jan 28, 2000 after 46 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: 2 generations back to K954192 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992897: Impregum Penta, Espe Dental AG (1999) Summary page 1.

## Most influential descendants
- K032001: Poly Q (Garant L, Penta M, Penta H) (2003), 2 descendants of its own
- K173318: Rapid HB, Rapid LB, Rapid MB (2017), 0 descendants of its own
- K080514: Pecd-01 and Pecd Quick-01 (2008), 0 descendants of its own

## Indications for use
Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PENTAMiX® 2 mixing device, resp.: Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant impressions

Source page: https://510kreport.com/device/K994192
Methodology: https://510kreport.com/methodology