# K250946: Denture Base Resin DT20

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
- Decided: Mar 31, 2025 after 3 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 5.

## Indications for use
Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture bases with Denture Base Resin requires a digital denture file, 3D printer and post-curing unit.

Source page: https://510kreport.com/device/K250946
Methodology: https://510kreport.com/methodology