The following data is part of a premarket notification filed by Sdi Limited with the FDA for Riva Star.
| Device ID | K172047 |
| 510k Number | K172047 |
| Device Name: | Riva Star |
| Classification | Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Applicant | SDI Limited 3-13 Brunsdon Street Bayswater, AU 3153 |
| Contact | Ray Cahill |
| Correspondent | Ray Cahill SDI Limited 3-13 Brunsdon Street Bayswater, AU 3153 |
| Product Code | PHR |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-06 |
| Decision Date | 2018-04-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RIVA STAR 86591727 5715719 Live/Registered |
SDI Limited 2015-04-09 |