# K081884: Major.Base 20

- Pathway: 510(k) (Abbreviated)
- Applicant: Major Prodotti Dentari S.P.A.
- Decided: Oct 8, 2008 after 98 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 K901789 (1990). 2 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901789: Paladon (R) 65, Kulzer, Inc. (1990) Summary page 1.
- K913655: Probase Hot and Probase Cold, Ivoclar North America, Inc. (1991) Summary page 1.

## Most influential descendants
- K102654: Vertex Rapid Simplified (2010), 20 descendants of its own
- 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

## Indications for use
Major.Base 20 is a denture base polymer for dental prosthesis. Poly-methylmethacrylate based. Heat-processed polymer. Powder and liquid. It is used for: - dental prosthesis - partial prosthesis - clasp prosthesis

Source page: https://510kreport.com/device/K081884
Methodology: https://510kreport.com/methodology