# K260569: DB 4000 High Impact Denture Base

- Pathway: 510(k) (Abbreviated)
- Applicant: Carbon, Inc.
- Decided: Jun 2, 2026 after 103 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K220979: SprintRay Denture Base, Sprintray, Inc. (2022) Summary page 5.

## Indications for use
DB 4000 High Impact Denture Base is indicated for the fabrication of dental devices for fully edentulous patients using additive manufacturing on 3D printers. This includes the fabrication of full removable dentures, overdentures, try-ins and temporary dentures. Fabrication of dental devices using DB 4000 High Impact Denture Base requires a digital denture file, digital light synthesis (DLP) 3D printer and curing light equipment. DB 4000 High Impact Denture Base can be utilized as an aid in bonding the denture teeth to the denture base.

Source page: https://510kreport.com/device/K260569
Methodology: https://510kreport.com/methodology