# K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress

- Pathway: 510(k) (Traditional)
- Applicant: Vertex-Dental B.V.
- Decided: Mar 25, 2011 after 192 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: 1 generation back to K913655 (1991). 2 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913655: Probase Hot and Probase Cold, Ivoclar North America, Inc. (1991) Summary page 1.
- K082153: Major.Repair, Major Prodotti Dentari S.P.A. (2008) Summary page 1.

## Most influential descendants
- K130076: Promolux, Promolux HI, Weropress, Premeco PCS (2013), 18 descendants of its own
- 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

## Indications for use
Vertex cold-curing denture base materials are indicated for: 1. Manufacture of full and partial dentures 2. Repair of full and partial dentures 3. Rebasing of full and partial dentures 4. Relining of full and partial dentures

Source page: https://510kreport.com/device/K102640
Methodology: https://510kreport.com/methodology