# K032267: R&D Designation AP-052-5

- Pathway: 510(k) (Traditional)
- Applicant: Jensen Industries, Inc.
- Decided: Sep 17, 2003 after 56 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: 2 generations back to K980613 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990670: Helioform Gold-Based Alloy, C. Hafner GmbH & Co. (1999) Summary page 1.

## Indications for use
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fused-to-metal technique of fabricating dental restorations. The mechanical and physical properties make AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors)

Source page: https://510kreport.com/device/K032267
Methodology: https://510kreport.com/methodology