# K190107: VeriSplint

- Pathway: 510(k) (Traditional)
- Applicant: Whip Mix Corporation
- Decided: Jul 10, 2019 after 169 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: 4 generations back to K924830 (1994). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150432: Idodentine Disc, Idodentine Block, Union Dental S.A. (2015) Summary page 4.

## Most influential descendants
- K203000: KeyPrint KeySplint Hard (2021), 6 descendants of its own
- K211415: GR Splint Resin System (2021), 2 descendants of its own
- K201173: E-Guard (2020), 2 descendants of its own
- K222061: Dental LT Clear V2 Resin (2022), 1 descendant of its own
- K253798: UltraPrint-Dental Hard Splint UV (2026), 0 descendants of its own

## Indications for use
Whip Mix VeriSplint is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

Source page: https://510kreport.com/device/K190107
Methodology: https://510kreport.com/methodology