# K021437: Secure Soft

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Jul 19, 2002 after 74 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
SECURE SOFT is intended for use as permanently soft relining for total and partial dentures. To relieve pressure from pressure spots To dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion To cushion sharp-edged alveolar processes To support the healing process in implantology

Source page: https://510kreport.com/device/K021437
Methodology: https://510kreport.com/methodology