# K030568: RADII

- Pathway: 510(k) (Traditional)
- Applicant: Southern Dental Industries, Inc.
- Decided: Apr 24, 2003 after 59 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- 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
- K052593: Fusion Curing Light (2005), 0 descendants of its own

## Indications for use
Polymerization of light curing dental materials with photo initiator for the wavelength range 440 - 480 nm. Suitable for light curing composite restorative materials, anterior composites, posterior composites, bonding agents, pit and fissure sealants, orthodontic adhesive and flowable composites.

Source page: https://510kreport.com/device/K030568
Methodology: https://510kreport.com/methodology