WAVE

Material, Tooth Shade, Resin

SOUTHERN DENTAL INDUSTRIES, INC.

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

Pre-market Notification Details

• Device ID: K973091
• 510k Number: K973091
• Device Name: WAVE
• Classification: Material, Tooth Shade, 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: EBF
• CFR Regulation Number: 872.3690 [🔎]
• 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
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