# K072522: Thermoform Sheet Materials and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Nov 16, 2007 after 70 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: 3 generations back to K780619 (1978). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062828: Mouthguard and Aligner Materials, Dentsply Intl., Inc. (2006) Summary page 1.

## Most influential descendants
- K200125: Thermoforming Sheet Materials (2020), 1 descendant of its own
- 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
- K080246: Composite Aligner Button (2008), 0 descendants of its own

## Indications for use
THERMOFORM SHEET MATERIALS AND ACCESSORIES are indicated for the fabrication of orthodontic and dental appliances.

Source page: https://510kreport.com/device/K072522
Methodology: https://510kreport.com/methodology