# K262300: Denture Base Resin V2

- Pathway: 510(k) (Abbreviated)
- Applicant: Formlabs Ohio, Inc.
- Decided: Jul 8, 2026 after 1 day
- 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: 7 generations back to K011560 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231578: Lucitone Digital Print Denture System, Dentsply Sirona (2023) Summary page 5.

## Indications for use
Denture Base Resin V2 is a light-curable resin indicated for the fabrication of denture bases, including full and partial removable dentures, implant overdentures, and other dental appliances. Denture Base Resin V2 is indicated to treat patients with complete or partial edentulism.

Source page: https://510kreport.com/device/K262300
Methodology: https://510kreport.com/methodology