# K241311: Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)

- Pathway: 510(k) (Traditional)
- Applicant: Bernhard Förster GmbH
- Decided: Aug 2, 2024 after 85 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: 5 generations back to K780619 (1978). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200125: Thermoforming Sheet Materials, Erkodent Erich Kopp GmbH (2020) Summary page 5.

## Indications for use
Thermoforming Sheet Materials Track A, B, E and Bleach are indicated for the fabrication of orthodontic and dental appliances.

Source page: https://510kreport.com/device/K241311
Methodology: https://510kreport.com/methodology