RADII

• K Number: K030568
• Device Name: RADII
• Manufacturer: SOUTHERN DENTAL INDUSTRIES, INC.
• Date Cleared: 2003-04-24 ( 59 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended 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.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental curing light (Radii), outlining its general information, regulation, and indications for use. It does not include details on acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the table or the detailed description of a study as requested.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.