# K913655: Probase Hot and Probase Cold

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Oct 17, 1991 after 65 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.
26 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress (2011), 23 descendants of its own
- K081884: Major.Base 20 (2008), 21 descendants of its own
- 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

Source page: https://510kreport.com/device/K913655
Methodology: https://510kreport.com/methodology