# K140894: Argen Pmma

- Pathway: 510(k) (Traditional)
- Applicant: The Argen Corporation
- Decided: Jul 31, 2014 after 114 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924830 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102341: Vipi Block, Vipi Industria,Comercio,Exportacao E Importacao DE (2010) Summary page 1.
- K071548: Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored, Merz Dental GmbH (2007) Summary page 1.
- K061809: Artegral Imcrown, Merz Dental GmbH (2006) Summary page 1.
- K060293: Temporary Crown and Bridge Material, Dentsply International, Inc. (2006) Summary page 1.

## Indications for use
ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill lang-ternm temporary substructures for crowns &bridgework. The blanks are intended to be used In various CAD/CAM systems.

Source page: https://510kreport.com/device/K140894
Methodology: https://510kreport.com/methodology