510(k) K240059
K240059 is an FDA 510(k) premarket notification submitted by Tedequim Srl for the device "FAgamin®". The FDA issued a decision of Substantially Equivalent on May 16, 2024. The device falls under product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish), a Class II device regulated under 21 CFR 872.3260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2024
- Date Received
- January 8, 2024
- 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.