# K974231: Position Penta, Position Penta Quick

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Jan 29, 1998 after 78 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 K812116 (1981). 3 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960547: Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive, Espe GmbH & Co. Kg. (1996) Summary page 1.

## Most influential descendants
- K131404: Flash AR Penta / Flash AR Penta Quick (2013), 2 descendants of its own
- K090718: Bellus Shading Kit (2009), 1 descendant of its own
- K133436: Flash AR; Flash AR Quick (2014), 0 descendants of its own
- K133400: Flash Bite (2014), 0 descendants of its own
- K130604: Universal Paste Stains and Glaze (2013), 0 descendants of its own

## Indications for use
Impressions for temporary restorations Preliminary impressions (all types) Impressions of opposing jaws Impressions for orthodontic models

Source page: https://510kreport.com/device/K974231
Methodology: https://510kreport.com/methodology