# K022206: Jensen Gold Foil

- Pathway: 510(k) (Traditional)
- Applicant: Jensen Industries, Inc.
- Decided: Aug 29, 2002 after 55 days
- Product code: EJT (Alloy, Gold-Based Noble Metal)
- Device class: 2
- Regulation: 21 CFR 872.3060
- 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 K915626 (1992). 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)
- K915626: EZ Gold, Ivoclar North America, Inc. (1992) Summary page 1.
- (no number) Williams Gold Foil: named in the summary without a submission number

## Indications for use
Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations.

Source page: https://510kreport.com/device/K022206
Methodology: https://510kreport.com/methodology