# K053060: TCS Unbreakable

- Pathway: 510(k) (Traditional)
- Applicant: Thermoplastic Comfort Systems, Inc.
- Decided: Jul 20, 2006 after 262 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
No predicates in its family tree.
21 later devices descend from it; 8 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123220: Vertex Thermosens Rigid (2013), 10 descendants of its own
- K132725: Juvora Dentqal Disc (2014), 8 descendants of its own
- K250617: Apex Flex (2025), 3 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

## Indications for use
TCS® Unbreakable is a break resistant material used in the fabrication and repair of base plates for removeable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not to be limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.

Source page: https://510kreport.com/device/K053060
Methodology: https://510kreport.com/methodology