The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Riva Protect.
| Device ID | K050871 |
| 510k Number | K050871 |
| Device Name: | RIVA PROTECT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 5 BRUNSDON ST 3125 Bayswater Vi 3125, AU |
| Contact | Ray Cahill |
| Correspondent | Ray Cahill SOUTHERN DENTAL INDUSTRIES, INC. 5 BRUNSDON ST 3125 Bayswater Vi 3125, AU |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-04-06 |
| Decision Date | 2005-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3686950001 | K050871 | 000 |
| DO3686905011 | K050871 | 000 |
| DO3686901011 | K050871 | 000 |
| DO3686900001 | K050871 | 000 |
| DO3686850001 | K050871 | 000 |
| DO3686809001 | K050871 | 000 |
| DO3686805011 | K050871 | 000 |
| DO3686801011 | K050871 | 000 |
| DO3686800001 | K050871 | 000 |