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
DO3675000001	K973091	000
DO3675122231	K973091	000
DO3675123241	K973091	000
DO3675133341	K973091	000
DO3675141421	K973091	000
DO3675141431	K973091	000
DO3675141471	K973091	000
DO3675200011	K973091	000
DO3675200021	K973091	000
DO3675200031	K973091	000
DO3675113141	K973091	000
DO3675112111	K973091	000
DO3675000111	K973091	000
DO3675000121	K973091	000
DO3675000131	K973091	000
DO3675101021	K973091	000
DO3675102031	K973091	000
DO3675102041	K973091	000
DO3675103041	K973091	000
DO3675104051	K973091	000
DO3675111011	K973091	000
DO3675200041	K973091	000
DO3682000001	K973091	000
DO3682101021	K973091	000
DO3683102041	K973091	000
DO3683103041	K973091	000
DO3683104051	K973091	000
DO3683111011	K973091	000
DO3683112111	K973091	000
DO3683122231	K973091	000
DO3683141471	K973091	000
DO3683200011	K973091	000
DO3683200021	K973091	000
DO3683102031	K973091	000
DO3683101021	K973091	000
DO3682102031	K973091	000
DO3682102041	K973091	000
DO3682103041	K973091	000
DO3682104051	K973091	000
DO3682111011	K973091	000
DO3682112111	K973091	000
DO3682122231	K973091	000
DO3682141471	K973091	000
DO3683000001	K973091	000
DO3683200031	K973091	000