# K183598: KeyPrint KeySplint Soft

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Industries
- Decided: Nov 15, 2019 after 324 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 11 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K203000: KeyPrint KeySplint Hard (2021), 6 descendants of its own
- K212448: NightGuard Flex (2021), 2 descendants of its own
- K211415: GR Splint Resin System (2021), 2 descendants of its own
- K222061: Dental LT Clear V2 Resin (2022), 1 descendant of its own
- K221022: NextDent Ortho Flex (2022), 1 descendant of its own

## Recalls of this device
- Jun 25, 2021 · Class II · Z-2336-2021: Product label intended for the European community was distributed to the USA market via their US distribution organization

## Indications for use
The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Source page: https://510kreport.com/device/K183598
Methodology: https://510kreport.com/methodology