RIVA-SELF CURE

Cement, Dental

SOUTHERN DENTAL INDUSTRIES, INC.

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

Pre-market Notification Details

• Device ID: K030516
• 510k Number: K030516
• Device Name: RIVA-SELF CURE
• Classification: Cement, Dental
• 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: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-19
• Decision Date: 2003-04-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
DO3686000011	K030516	000
DO3686050031	K030516	000
DO3686050041	K030516	000
DO3686050051	K030516	000
DO3686050071	K030516	000
DO3686050081	K030516	000
DO3686100001	K030516	000
DO3686101011	K030516	000
DO3686101021	K030516	000
DO3686101031	K030516	000
DO3686050021	K030516	000
DO3686050011	K030516	000
DO3686000021	K030516	000
DO3686000031	K030516	000
DO3686000041	K030516	000
DO3686000051	K030516	000
DO3686000071	K030516	000
DO3686000081	K030516	000
DO3686000111	K030516	000
DO3686000121	K030516	000
DO3686000131	K030516	000
DO3686101051	K030516	000
DO3686101081	K030516	000
DO3686200041	K030516	000
DO3686200051	K030516	000
DO3686200061	K030516	000
DO3686200071	K030516	000
DO3686300011	K030516	000
DO3686300021	K030516	000
DO3686300031	K030516	000
DO3686300041	K030516	000
DO3688000001	K030516	000
DO3686200001	K030516	000
DO3686105231	K030516	000
DO3686105011	K030516	000
DO3686105021	K030516	000
DO3686105031	K030516	000
DO3686105041	K030516	000
DO3686105051	K030516	000
DO3686105071	K030516	000
DO3686105081	K030516	000
DO3686105211	K030516	000
DO3686105221	K030516	000
DO3688001001	K030516	000