510(k) K222459
K222459 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "Centrix FluoroSilver Silver Diamine Fluoride 38%". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish), a Class II device regulated under 21 CFR 872.3260. Centrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2023
- Date Received
- August 15, 2022
- 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.