# K253365: LuxCreo Flexible Partial Denture Resin

- Pathway: 510(k) (Traditional)
- Applicant: LuxCreo, Inc.
- Decided: Nov 25, 2025 after 56 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: 8 generations back to K011560 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250617: Apex Flex, Sprintray, Inc. (2025) Summary page 8.
- K250489: FP3D, Keystone Industries (2025) Summary page 8.

## Indications for use
LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics. LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant.

Source page: https://510kreport.com/device/K253365
Methodology: https://510kreport.com/methodology