# K143486: Ufi Gel hard C

- Pathway: 510(k) (Special)
- Applicant: Voco GmbH
- Decided: Jan 7, 2015 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
- hard permanent total or partial relinings for restoring partial and complete dentures - lengthening denture margins

Source page: https://510kreport.com/device/K143486
Methodology: https://510kreport.com/methodology