# K201091: V-Print splint

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Nov 6, 2020 after 197 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
– Therapeutic splints – Auxiliary parts and functional parts for diagnostics – Manufacturing of patient-matched night guards/splints

Source page: https://510kreport.com/device/K201091
Methodology: https://510kreport.com/methodology