# K203641: E-Denture Pro

- Pathway: 510(k) (Traditional)
- Applicant: Envisiontec GmbH
- Decided: Mar 30, 2021 after 106 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.
3 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)
- K191497: NextDent Denture 3D+, Vertex-Dental B.V. (2019) Summary page 4.

## Most influential descendants
- K241089: KeyPrint KeyDenture Base (2024), 2 descendants of its own
- K250489: FP3D (2025), 1 descendant of its own
- K253365: LuxCreo Flexible Partial Denture Resin (2025), 0 descendants of its own

## Indications for use
E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases fabricated in dental laboratories for full removable dentures. The material is an alternative to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro requires a computer-aided and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.

Source page: https://510kreport.com/device/K203641
Methodology: https://510kreport.com/methodology