K172047 is an FDA 510(k) clearance for the Riva Star. This device is classified as a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II - Special Controls, product code PHR).
Submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on April 11, 2018, 279 days after receiving the submission on July 6, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260. Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity..
| 510(k) Number | K172047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2017 |
| Decision Date | April 11, 2018 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PHR - Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |
| Definition | Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity. |