# K212448: NightGuard Flex

- Pathway: 510(k) (Traditional)
- Applicant: Sprintray, Inc.
- Decided: Nov 12, 2021 after 99 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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 5.

## Most influential descendants
- K221022: NextDent Ortho Flex (2022), 1 descendant of its own
- K251415: Additively Manufactured Aligner Resin (2025), 0 descendants of its own

## Indications for use
The SprintRay NightGuard Flex is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Source page: https://510kreport.com/device/K212448
Methodology: https://510kreport.com/methodology