# K242884: Additively Manufactured Denture Resin

- Pathway: 510(k) (Traditional)
- Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
- Decided: Nov 22, 2024 after 60 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200461: Freeprint denture, Detax GmbH & Co. KG (2020) Summary page 5.

## Indications for use
Additively Manufactured Denture Resin is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. Additively Manufactured Denture Resin is intended for continuous use in the oral environment, exclusively for professional dental work. Additively Manufactured Denture Resin can be used in combination with a OLP 3D printers utilizing wavelengths at 385nm or 405nm. A 3D-printer is not part of the device.

Source page: https://510kreport.com/device/K242884
Methodology: https://510kreport.com/methodology