510(k) K250222
K250222 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "SDF Pro". The FDA issued a decision of Substantially Equivalent on May 7, 2025. The device falls under product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish), a Class II device regulated under 21 CFR 872.3260. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2025
- Date Received
- January 27, 2025
- 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.