# K212017: Thermeo System

- Pathway: 510(k) (Traditional)
- Applicant: Pro3Dure Medical GmbH
- Decided: Apr 8, 2022 after 284 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: 6 generations back to K924830 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111828: Clearsplint ES, Astron Dental Corporation (2011) Summary page 4.
- K192153: Portux CAD/CAM Disc, New Stetic, SA (2019) Summary page 4.

## Most influential descendants
- K260031: Thermeo® I Msi (2026), 0 descendants of its own

## Indications for use
Thermeo powder / Thermeo liquid is a heat cured, moldable, acrylic compound system for use in the fabrication of dental appliances such as mouthguards, nightguards, bruxism and TMJ splint appliances, and bite splints. The Thermeo 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/K212017
Methodology: https://510kreport.com/methodology