# K080182: Zeno Pmma Disc

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Apr 8, 2008 after 74 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: 1 generation back to K070991 (2007). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070991: Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310, Vita (2007) Summary page 1.

## Most influential descendants
- K122025: Brightglass Brightglass M (2012), 6 descendants of its own
- K131664: Copra Temp Pmma-Disk (2013), 4 descendants of its own
- K141421: Pmma Block (2015), 2 descendants of its own
- K190217: Aidite PMMA (2020), 1 descendant of its own
- K112967: Pmma Cad/Cam Disc (2012), 1 descendant of its own

## Indications for use
ZENO®PMMA Discs are milling blanks consisting of polymethylmethacrylate. They are designed for making long-term temporary crown and bridge work and have to be machined with the CAD/CAM technique. ZENO PMMA Discs are recommended for manufacturing substructures of single tooth and bridgework with one or two pontics.

Source page: https://510kreport.com/device/K080182
Methodology: https://510kreport.com/methodology