# K974282: Vitalescence

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jan 29, 1998 after 76 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Aug 2, 2024 · Class II · Z-3066-2024: Due to a manufacturing issue, red particulates present in the expressed composite.

## Indications for use
Vitalescence is used for direct and indirect esthetic restorations in anterior and posterior sections.

Source page: https://510kreport.com/device/K974282
Methodology: https://510kreport.com/methodology