RADII

Activator, Ultraviolet, For Polymerization

SOUTHERN DENTAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Radii.

Pre-market Notification Details

• Device ID: K030568
• 510k Number: K030568
• Device Name: RADII
• Classification: Activator, Ultraviolet, For Polymerization
• Applicant: SOUTHERN DENTAL INDUSTRIES, INC. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106
• Contact: Samantha J Cheetham
• Correspondent: Samantha J Cheetham; SOUTHERN DENTAL INDUSTRIES, INC. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106
• Product Code: EBZ
• CFR Regulation Number: 872.6070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-24
• Decision Date: 2003-04-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
DO3656002021	K030568	000
DO3656001021	K030568	000