# K991913: Pentamix 2

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Jul 26, 1999 after 49 days
- Product code: EFD (Amalgamator, Dental, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.3100
- 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 K891064 (1989). 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)
- K891064: Espe Capmix, Espe GmbH (Us) (1989) Summary page 1.

## Indications for use
Automatic mixing, dosing and dispensing system for ESPE’s PENTA impression and bite registration materials: IMPREGUM® PENTA PERMADYNE® PENTA H PERMADYNE® PENTA L RAMITEC® PENTA DIMENSION® PENTA H DIMENSION® PENTA H QUICK DIMENSION® PENTA L POSITION® PENTA POSITION® PENTA QUICK

Source page: https://510kreport.com/device/K991913
Methodology: https://510kreport.com/methodology