# K201827: GR-17 Resin System

- Pathway: 510(k) (Traditional)
- Applicant: Pro3Dure Medical GmbH
- Decided: Nov 5, 2020 after 126 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070991 (2007). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102776: Extra-Oral, Additive Computer Aided Manufacture and Curing System, Deltamed GmbH (2011) Summary page 4.

## Most influential descendants
- K261261: Dura-Arch (2026), 0 descendants of its own

## Indications for use
The GR-17 Resin System is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. The GR-17 temporary is indicated for the fabrication, by additive manufacturing, of temporary anterior dental restorations. The GR-17.1 temporary is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and for the fabrication, by additive manufacturing, of preformed denture teeth to be used in a denture.

Source page: https://510kreport.com/device/K201827
Methodology: https://510kreport.com/methodology