# K140758: M-PM-Disc (Pink)

- Pathway: 510(k) (Traditional)
- Applicant: Merz Dental GmbH
- Decided: Sep 15, 2014 after 173 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K901789 (1990). 11 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130076: Promolux, Promolux HI, Weropress, Premeco PCS, Merz Dental GmbH (2013) Summary page 4.
- K071548: Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored, Merz Dental GmbH (2007) Summary page 4.

## Most influential descendants
- K151142: Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid (2015), 14 descendants of its own
- K210977: E-Dent 1000 (2021), 7 descendants of its own
- K222623: Digital Crown (2022), 4 descendants of its own
- K230445: OnX Tough (2023), 2 descendants of its own
- K242277: Crown HT (2024), 1 descendant of its own

## Indications for use
Device for fabrication of dental bases for removable dentures.

Source page: https://510kreport.com/device/K140758
Methodology: https://510kreport.com/methodology