# K082153: Major.Repair

- Pathway: 510(k) (Traditional)
- Applicant: Major Prodotti Dentari S.P.A.
- Decided: Nov 25, 2008 after 118 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
No predicates in its family tree.
24 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress (2011), 23 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.Repair is a cold-curing polymer for dental prosthesis. Poly-methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid. It is used to: - repair and rebase prosthesis - temporary prosthesis

Source page: https://510kreport.com/device/K082153
Methodology: https://510kreport.com/methodology