# K203000: KeyPrint KeySplint Hard

- Pathway: 510(k) (Traditional)
- Applicant: Mycone Dental Supply Co. Inc. (Dba Keystone Industries)
- Decided: Apr 9, 2021 after 190 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
Longest line of descent: 5 generations back to K924830 (1994). 7 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183598: KeyPrint KeySplint Soft, Keystone Industries (2019) Summary page 4.
- K190107: VeriSplint, Whip Mix Corporation (2019)

## Most influential descendants
- K211415: GR Splint Resin System (2021), 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
- K231775: GR Resin System MSI (2024), 0 descendants of its own
- K232087: Dental LT Comfort Resin (2024), 0 descendants of its own

## Recalls of this device
- Nov 20, 2023 · Class II · Z-0630-2024: Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instr

## Indications for use
The KeyPrint" KeySplint HardTM 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/K203000
Methodology: https://510kreport.com/methodology