# K223798: Glidewell TuffSplint™ Appliance Resin

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Feb 17, 2023 after 60 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: 1 generation back to K183598 (2019). 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)
- K183598: KeyPrint KeySplint Soft, Keystone Industries (2019) Summary page 4.

## Indications for use
Glidewell TuffSplint™ Appliance Resin is indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, splints and repositioners.

Source page: https://510kreport.com/device/K223798
Methodology: https://510kreport.com/methodology