510(k) K262478
K262478 is an FDA 510(k) premarket notification submitted by BCS Device Pte., Ltd. for the device "BCS Bioceramic Sealer". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2026
- Date Received
- Jul 20, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type
- 510(k)