# K111177: Juell Hard Cure

- Pathway: 510(k) (Traditional)
- Applicant: Juell Dental
- Decided: Sep 12, 2011 after 138 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: 1 generation back to K030916 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030916: Ufi Gel Hard C, Voco GmbH (2003) Summary page 2.

## Indications for use
JuellCure Hard is intended for use as a permanent hard relining for total and partial dentures *Hard permanent total or partial relining for restoring partial and complete dentures *Lengthening denture margins

Source page: https://510kreport.com/device/K111177
Methodology: https://510kreport.com/methodology