# K260376: Denture Base

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huge Dental Material Corporation
- Decided: May 6, 2026 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: 6 generations back to K011560 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220042: Dentca Base Premium, Dentca Base Hi-Impact, Dentca, Inc. (2022) Summary page 5.
- K221678: SprintRay High Impact Denture Base, Sprintray, Inc. (2022) Summary page 5.

## Indications for use
Denture Base is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. Denture Base can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures. Denture Base can be utilized as an aid in bonding the denture teeth onto denture base.

Source page: https://510kreport.com/device/K260376
Methodology: https://510kreport.com/methodology