# K182065: Evolux Cad/Cam Pmma Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Blue Dent Dental
- Decided: Dec 13, 2018 after 134 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology. Indications: - Temporary anterior and posterior crowns - Temporary anterior and posterior bridges with up to two adjacent pontics - Implant supported temporary restorations Maximum recommended usage period: 12 months - Removable structures for dentures (dental bases) - Removable structures for therapeutic restorations (bite splints or occlusal splints)

Source page: https://510kreport.com/device/K182065
Methodology: https://510kreport.com/methodology