# K222604: dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S

- Pathway: 510(k) (Traditional)
- Applicant: Dentona AG
- Decided: Apr 21, 2023 after 235 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
Dentona vivatemp and Dentona flexisplint (powder/liquid) are heat cured, moldable, acrylic compound systems for use in the fabrication of dental appliances such as splints, night guards, mouthguards and bruxism appliances. The optimill memosplint blank and the optimill memosplint version S blank are discs intended for the fabrication of dental appliances such as splints, night guards, mouthguards and bruxism appliances using CAD/CAM milling machines.

Source page: https://510kreport.com/device/K222604
Methodology: https://510kreport.com/methodology