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The Bell BriefFrom Dr. Jennifer Bell, DDS
BACKGROUNDRegulatoryTier 1

FDA 510(k) K261728: One-Fil LC

SourceopenFDA Dental DevicesTier 1Hard News

By U.S. FDA / openFDA

Originally at accessdata.fda.gov

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

General dentists and restorative teams now have a new calcium-hydroxide liner option cleared via 510(k), potentially widening material choices for direct and indirect pulp capping.

Key points

  • Mediclus Co., Ltd. received clearance for One-Fil LC, a light-cured cavity liner under product code EJK (Regulation 872.3250).
  • Device is Class II and labeled substantially equivalent to predicate liners already on the market.
  • Adds a new branded product to the calcium-hydroxide liner category without altering existing clinical protocols or billing codes.
  • No recall, safety alert, or change in regulatory requirements accompanies this clearance.

Who should care

OwnerAssociateStaff

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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