# K120438: Flash (Different Materials)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Deutschland GmbH
- Decided: May 2, 2012 after 79 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 K863288 (1986). 8 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051797: Future Wash/Yps, 3M Espe AG Dental Products (2005) Summary page 2.
- K000591: Dimension Penta H, Dimension Penta H Quick, Espe Dental AG (2000) Summary page 2.
- K963766: 3M Proplus System, 3M Company (1996) Summary page 2.

## Most influential descendants
- 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
- K133400: Flash Bite (2014), 0 descendants of its own

## Indications for use
Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g.: crown, bridge, inlay and onlay preparations).

Source page: https://510kreport.com/device/K120438
Methodology: https://510kreport.com/methodology