# K130076: Promolux, Promolux HI, Weropress, Premeco PCS

- Pathway: 510(k) (Traditional)
- Applicant: Merz Dental GmbH
- Decided: Aug 22, 2013 after 220 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: 3 generations back to K901789 (1990). 6 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102654: Vertex Rapid Simplified, Vertex-Dental B.V. (2010) Summary page 1.
- K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress, Vertex-Dental B.V. (2011) Summary page 1.

## Most influential descendants
- K140758: M-PM-Disc (Pink) (2014), 17 descendants of its own
- 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

## Indications for use
The Menz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for: Relining a denture surface that contacts tissue Repairing a fractured denture, or Fanning a new denture base

Source page: https://510kreport.com/device/K130076
Methodology: https://510kreport.com/methodology