FDA 510(k) K262050: Vioseal X
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
Routine clearance of another resin-based root-canal filler allows endodontic practices to add Vioseal X to their material options, but brings no new regulatory or reimbursement impact.
Key points
- Product is a Class II device cleared under 510(k) K262050 via substantial equivalence to prior predicate materials.
- Regulation 872.3820 and product code KIF cover resin root-canal filling materials used by endodontists and general dentists.
- Spident Co., Ltd. is the manufacturer; clearance does not alter existing FDA oversight or billing codes.
- No effective date or implementation timeline stated in the 510(k) summary.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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