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
DO3656000111	K030568	000
D6620708540262	K030568	000
D6620708540180	K030568	000
D6620708540000	K030568	000
D66207085320029	K030568	000
D6620708507350	K030568	000