The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Riva Luting Plus.
| Device ID | K062065 |
| 510k Number | K062065 |
| Device Name: | RIVA LUTING PLUS |
| Classification | Cement, Dental |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Contact | Ray Cahill |
| Correspondent | Ray Cahill 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 | 2006-07-20 |
| Decision Date | 2006-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3686519001 | K062065 | 000 |
| DO3686515081 | K062065 | 000 |
| DO3686511081 | K062065 | 000 |
| DO3686510081 | K062065 | 000 |