The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Riva Silver.
| Device ID | K042452 |
| 510k Number | K042452 |
| Device Name: | RIVA SILVER |
| 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 | Yes |
| Date Received | 2004-09-10 |
| Decision Date | 2004-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3686709001 | K042452 | 000 |
| DO3686705081 | K042452 | 000 |
| DO3686701081 | K042452 | 000 |
| DO3686700081 | K042452 | 000 |