# K062828: Mouthguard and Aligner Materials

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Nov 27, 2006 after 68 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: 2 generations back to K780619 (1978). 6 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053580: Doctor's Nightguard, Dental Concepts, LLC (2006) Summary page 1.
- K022809: EZ Splint & EZ Splint PM, Power Products, Inc.-Splintek (2003) Summary page 1.
- K981095: Align System, Align Technology (1998) Summary page 1.

## Most influential descendants
- K072522: Thermoform Sheet Materials and Accessories (2007), 3 descendants of its own
- K200125: Thermoforming Sheet Materials (2020), 1 descendant of its own
- K134015: M-PM-Disc (2014), 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
- K191836: Ceramill A-Splint (2019), 0 descendants of its own

## Indications for use
MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.

Source page: https://510kreport.com/device/K062828
Methodology: https://510kreport.com/methodology