510(k) K250778
K250778 is an FDA 510(k) premarket notification submitted by Dsi Dental Solutions, Ltd. for the device "Sil-Flow". The FDA issued a decision of Substantially Equivalent on May 23, 2025. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Dsi Dental Solutions, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2025
- Date Received
- March 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type