# K200461: Freeprint denture

- Pathway: 510(k) (Traditional)
- Applicant: Detax GmbH & Co. KG
- Decided: Nov 16, 2020 after 265 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: 4 generations back to K011560 (2001). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162572: NextDent Denture, E-Denture, Vertex-Dental B.V. (2017) Summary page 4.

## Most influential descendants
- K253324: UltraPrint-Dental Denture UV (2025), 0 descendants of its own
- K252430: Freeprint® denture flex (2025), 0 descendants of its own
- K242884: Additively Manufactured Denture Resin (2024), 0 descendants of its own

## Indications for use
FREEPRINT denture is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. FREEPRINT denture is intended for continuous use in the oral environment, exclusively for professional dental work. FREEPRINT denture can be used in combination with a stereolithographic 3D printer using a 385nm light source. A 3D-printer is not part of the device.

Source page: https://510kreport.com/device/K200461
Methodology: https://510kreport.com/methodology