# K241089: KeyPrint KeyDenture Base

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Industries
- Decided: Oct 24, 2024 after 188 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: 6 generations back to K011560 (2001). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203641: E-Denture Pro, Envisiontec GmbH (2021) Summary page 5.

## Most influential descendants
- K250489: FP3D (2025), 1 descendant of its own
- K253365: LuxCreo Flexible Partial Denture Resin (2025), 0 descendants of its own

## Indications for use
KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable dentures, in dental laboratories. Fabrication requires a computer-aided design and manufacturing (CAD/CAM) system and 3D printer.

Source page: https://510kreport.com/device/K241089
Methodology: https://510kreport.com/methodology