# K211415: GR Splint Resin System

- Pathway: 510(k) (Traditional)
- Applicant: Pro3Dure Medical GmbH
- Decided: Oct 21, 2021 after 168 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.
2 later devices descend from it; 2 cite it directly.
0 of 11 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 4.
- K183598: KeyPrint KeySplint Soft, Keystone Industries (2019) Summary page 4.

## Most influential descendants
- K231775: GR Resin System MSI (2024), 0 descendants of its own
- K232448: FREEPRINT® splintmaster (2023), 0 descendants of its own

## Indications for use
The GR Splint Resin System is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment: The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints. The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers. The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.

Source page: https://510kreport.com/device/K211415
Methodology: https://510kreport.com/methodology