# K253798: UltraPrint-Dental Hard Splint UV

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Heygears IMC., Inc.
- Decided: Mar 2, 2026 after 94 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: 6 generations back to K924830 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203000: KeyPrint KeySplint Hard, Mycone Dental Supply Co. Inc. (Dba Keystone Industries) (2021) Summary page 5.

## Indications for use
The UltraPrint-Dental Hard Splint UV device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.

Source page: https://510kreport.com/device/K253798
Methodology: https://510kreport.com/methodology