# K202965: CURA-Temp

- Pathway: 510(k) (Traditional)
- Applicant: Mgnewton, Ltd.
- Decided: Dec 21, 2022 after 812 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
Longest line of descent: 5 generations back to K902115 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073296: TEMPXN28, 3M Espe AG Dental Products (2008) Summary page 4.

## Indications for use
Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.

Source page: https://510kreport.com/device/K202965
Methodology: https://510kreport.com/methodology