# K210298: GR-14 Resin System

- Pathway: 510(k) (Traditional)
- Applicant: Pro3Dure Medical GmbH
- Decided: May 5, 2021 after 91 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011560 (2001). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191497: NextDent Denture 3D+, Vertex-Dental B.V. (2019) Summary page 4.
- K162044: Dentca Denture Base II, Dentca, Inc. (2017) Summary page 4.

## Most influential descendants
- K213765: Glidewell 3DP Denture Base Resin (2022), 2 descendants of its own
- K261802: Glidewell™ Denture Base Resin (2026), 0 descendants of its own
- K241493: Glidewell™ 3DP Denture Base Resin (2024), 0 descendants of its own

## Indications for use
The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. The GR-14.2 denture HI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Source page: https://510kreport.com/device/K210298
Methodology: https://510kreport.com/methodology