# K971575: Benchmark-IV

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Jun 4, 1997 after 58 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
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
1t 45 palladium gree, nich gold colored, Type-1V extra hard alloy fon Hand Inlays, Crowns, Fixed Bridgewonrk. This High noble alloy oifens strength, nesilency and hardness fon harnd inlays and Longspan bridges.lt resists tarnish and discolonation and can be quenched (So4t | and heat-treated ( Hardened ).I1t can be wused forn restorative wonks.

Source page: https://510kreport.com/device/K971575
Methodology: https://510kreport.com/methodology