# K973247: Vintage Halo

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Oct 16, 1997 after 48 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K052189: Reveneer Ceramic Repair System (2005), 0 descendants of its own

## Indications for use
Vintage HALO is a Dental Ceramic Fused-to-Metal Restorative Material.

Source page: https://510kreport.com/device/K973247
Methodology: https://510kreport.com/methodology