STAE

Agent, Tooth Bonding, Resin

SOUTHERN DENTAL INDUSTRIES, INC.

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

Pre-market Notification Details

• Device ID: K973092
• 510k Number: K973092
• Device Name: STAE
• Classification: Agent, Tooth Bonding, Resin
• Applicant: SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105
• Contact: Samantha J Cheetham
• Correspondent: Samantha J Cheetham; SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-18
• Decision Date: 1997-12-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
DO3681002051	K973092	000
DO3681002021	K973092	000
DO3681002011	K973092	000