MEDIUMRegulatoryTier 1
FDA 510(k) K262478: BCS Bioceramic Sealer
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Practice owners and endodontists evaluating root-canal filling materials now have an additional FDA-cleared bioceramic sealer option available for purchase.
Key points
- BCS Device Pte., Ltd. received 510(k) clearance K262478 for the BCS Bioceramic Sealer.
- The device is classified as a Class 2 resin root-canal filling material under regulation 872.3820.
- Clearance was granted through the traditional substantially-equivalent pathway.
- Product code KIF identifies the device within the FDA dental-device database.
Who should care
OwnerSpecialist
Read the original on openFDA Dental Devices
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