# K142894: TCS Blend

- Pathway: 510(k) (Traditional)
- Applicant: Thermoplastic Comfort Systems, Inc.
- Decided: Feb 3, 2015 after 123 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 K053060 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
TCS Blend is a break resistant material used for the fabrication and repair of base plates for removable dental prosthetic appliances. This includes, but not to be limited to, partial or full removable dentures, orthodontic devices, occlusal splints and night guards.

Source page: https://510kreport.com/device/K142894
Methodology: https://510kreport.com/methodology