# K200125: Thermoforming Sheet Materials

- Pathway: 510(k) (Traditional)
- Applicant: Erkodent Erich Kopp GmbH
- Decided: Oct 28, 2020 after 281 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: 4 generations back to K780619 (1978). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072522: Thermoform Sheet Materials and Accessories, Dentsply International, Inc. (2007) Summary page 5.
- K062828: Mouthguard and Aligner Materials, Dentsply Intl., Inc. (2006) Summary page 5.

## Most influential descendants
- K241311: Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) (2024), 0 descendants of its own

## Indications for use
Thermoforming Sheet Materials are indicated for the fabrication of orthodontic and dental appliances.

Source page: https://510kreport.com/device/K200125
Methodology: https://510kreport.com/methodology