510(k) K262982
K262982 is an FDA 510(k) premarket notification submitted by Spident Co., Ltd. for the device "Core·it Dual". The FDA issued a decision of Substantially Equivalent on Sep 21, 2026. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Spident Co., Ltd. has 21 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2026
- Date Received
- Aug 27, 2026
- Clearance Type
- Special
- 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
- 510(k)