# K973265: Verabond 2V

- Pathway: 510(k) (Traditional)
- Applicant: Aalba Dent, Inc.
- Decided: Oct 16, 1997 after 48 days
- Product code: EJH (Alloy, Metal, Base)
- Device class: 2
- Regulation: 21 CFR 872.3710
- 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
This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.

Source page: https://510kreport.com/device/K973265
Methodology: https://510kreport.com/methodology