# K192153: Portux CAD/CAM Disc

- Pathway: 510(k) (Traditional)
- Applicant: New Stetic, SA
- Decided: Nov 7, 2019 after 90 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 K924830 (1994). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180578: Harvest Dental Polymer Blocks, Harvest Dental Products, LLC (2018) Summary page 4.

## Most influential descendants
- K212017: Thermeo System (2022), 1 descendant of its own
- K260031: Thermeo® I Msi (2026), 0 descendants of its own

## Indications for use
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics. - Provisional anterior and posterior crowns & bridges - Implant and abutment supported prosthetics. - Partial, complete and hybrid denture prosthetics (base and teeth) — Removable appliances (splint)

Source page: https://510kreport.com/device/K192153
Methodology: https://510kreport.com/methodology