# K250489: FP3D

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Industries
- Decided: May 20, 2025 after 90 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: 7 generations back to K011560 (2001). 8 ancestors in all.
1 later device descends 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)
- K241089: KeyPrint KeyDenture Base, Keystone Industries (2024)
- K063626: Duraflex, Cosmetic Dental Materials, Inc. (2007) Summary page 5.

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

## Indications for use
FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.

Source page: https://510kreport.com/device/K250489
Methodology: https://510kreport.com/methodology