# K021971: Ceraloy

- Pathway: 510(k) (Traditional)
- Applicant: Neirynck & Vogt NV
- Decided: Aug 1, 2002 after 45 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
Ceraloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, % crowns, veneers, inlays long and short span bridgework and P F M restorations.

Source page: https://510kreport.com/device/K021971
Methodology: https://510kreport.com/methodology