# K984140: Mainbond a

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Jan 13, 1999 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
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
Mainbond A is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application and compatible with low fusing porcelains in the market. Mainbond A is a rich yellow color, palladium free alloy and it provides quality restoration. It can also be used as Type-IV crown and bridge alloy. It polishes to a high luster and can be used for single, 3 to 4 crowns.

Source page: https://510kreport.com/device/K984140
Methodology: https://510kreport.com/methodology