# K111178: Juell Soft 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 K974772 (1998). 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)
- K974772: Ufi Gel C, Voco GmbH (1998) Summary page 1.

## Indications for use
JUELL~ure Soft is indicated for use as a permanent soft relining for total and partial dentures: - to relieve pressure from pressure points - to dam the palatal vibrating line - in cases of flabby ridge and/or insufficient adhesion - to cushion sharp-edged alveolar processes

Source page: https://510kreport.com/device/K111178
Methodology: https://510kreport.com/methodology