# K221022: NextDent Ortho Flex

- Pathway: 510(k) (Abbreviated)
- Applicant: Vertex-Dental B.V.
- Decided: Oct 21, 2022 after 198 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 K183598 (2019). 2 ancestors in all.
1 later device descends 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)
- K212448: NightGuard Flex, Sprintray, Inc. (2021) Summary page 4.

## Most influential descendants
- K251415: Additively Manufactured Aligner Resin (2025), 0 descendants of its own

## Indications for use
NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition. NextDent Ortho Flex is intended exclusively for professional dental work.

Source page: https://510kreport.com/device/K221022
Methodology: https://510kreport.com/methodology