# K042638: Radiance Porcelain

- Pathway: 510(k) (Traditional)
- Applicant: Aurident, Inc.
- Decided: Dec 17, 2004 after 81 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
Longest line of descent: 2 generations back to K900209 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981490: Willi Geller Creation Porcelain, Jensen Industries, Inc. (1998) Summary page 1.
- K954761: Finesse Low-Fusing Porcelain System, Dentsply Intl. (1995) Summary page 1.
- K921474: Vita Omega Porcelain, Vident (1992) Summary page 1.

## Indications for use
Radiance Porcelain is a sodium/potassium alumina silicate leucite glass ceramic porcelain system for the fabrication of dental restorations, crowns, bridges, veneers, inlays, and onlays, using either dental alloys or its pressable component, Press-I-Dent. This porcelain system is a lower fusing porcelain than feldspar based porcelains and is manufactured from the fritting of manufactured glass compositions. In addition, it has lower opposing occlusal wear characteristics than feldspar based porcelains. Radiance is intended for use by dental laboratories as an alternative to other porcelains.

Source page: https://510kreport.com/device/K042638
Methodology: https://510kreport.com/methodology