# K261456: Ruthinium Disc

- Pathway: 510(k) (Traditional)
- Applicant: Dental Manufacturing S.p.A.
- Decided: Aug 5, 2026 after 96 days
- Product code: POW (Crown And Bridge, Long-Term 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: 2 generations back to K093708 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172281: PuRE PMMA Disc, Quest Dental USA Corp. (2017) Summary page 5.

## Indications for use
The Ruthinium Disc is a polymethyl methacrylate (PMMA) blank intended for use in CAD/CAM systems for the fabrication of long-term temporary crowns and bridges, until permanent restorations can be delivered.

Source page: https://510kreport.com/device/K261456
Methodology: https://510kreport.com/methodology