510(k) K172047
K172047 is an FDA 510(k) premarket notification submitted by Sdi Limited for the device "Riva Star". The FDA issued a decision of Substantially Equivalent on April 11, 2018. The device falls under product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish), a Class II device regulated under 21 CFR 872.3260. Sdi Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2018
- Date Received
- July 6, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diammine Silver Fluoride Dental Hypersensitivity Varnish
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.