510(k) K240619
K240619 is an FDA 510(k) premarket notification submitted by Kids-E-Dental Llp for the device "e-SDF". The FDA issued a decision of Substantially Equivalent on March 6, 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
- March 6, 2024
- Date Received
- March 5, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.