# K123220: Vertex Thermosens Rigid

- Pathway: 510(k) (Traditional)
- Applicant: Vertex-Dental B.V.
- Decided: Mar 1, 2013 after 137 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992956 (1999). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053060: TCS Unbreakable, Thermoplastic Comfort Systems, Inc. (2006) Summary page 1.
- K992956: Lucitone FRS Flexibel Dental Resin, Dentsply Intl. (1999) Summary page 1.

## Most influential descendants
- K132725: Juvora Dentqal Disc (2014), 8 descendants of its own
- K160918: JUVORA Dental Disc, Ceramill PEEK by JUVORA (2017), 3 descendants of its own
- K152113: BioHPP - breCAM.BioHPP (2016), 3 descendants of its own
- K220329: G-CAM (2022), 1 descendant of its own
- K253236: G-Block (2025), 0 descendants of its own

## Indications for use
Vertex ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.

Source page: https://510kreport.com/device/K123220
Methodology: https://510kreport.com/methodology