# K260031: Thermeo® I Msi

- Pathway: 510(k) (Traditional)
- Applicant: Pro3Dure Medical GmbH
- Decided: Sep 29, 2026 after 266 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924830 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212017: Thermeo System, Pro3Dure Medical GmbH (2022) Summary page 5.

## Indications for use
The THERMEO® | MSI blank is a disc intended for the fabrication of dental appliances such as mouthguards, nightguards, bruxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.

Source page: https://510kreport.com/device/K260031
Methodology: https://510kreport.com/methodology