# K971002: Smile with Confidence

- Pathway: 510(k) (Traditional)
- Applicant: Lloyd V. Ziemendorf
- Decided: Jul 15, 1997 after 118 days
- Product code: EHS (Cushion, Denture, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 872.3540
- 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
An over the counter product for the temporary relief of [illegible OCR]

Source page: https://510kreport.com/device/K971002
Methodology: https://510kreport.com/methodology