# K000591: Dimension Penta H, Dimension Penta H Quick

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Mar 30, 2000 after 37 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051797: Future Wash/Yps (2005), 5 descendants of its own
- K120438: Flash (Different Materials) (2012), 4 descendants of its own
- K131404: Flash AR Penta / Flash AR Penta Quick (2013), 2 descendants of its own
- K140602: Flash Penta MB Quick, Flash MB Quick (2014), 0 descendants of its own
- K133436: Flash AR; Flash AR Quick (2014), 0 descendants of its own

## Recalls of this device
- Nov 21, 2013 · Class II · Z-0535-2014: Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the de

Source page: https://510kreport.com/device/K000591
Methodology: https://510kreport.com/methodology