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 |