FDA 510(k) K254201: Any-Cem
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
Dental practices can now add another Class II resin-based cement option to their restorative inventory; owners and procurement staff should verify whether pricing or handling characteristics justify switching from current adhesives.
Key points
- Any-Cem cleared 4 Feb 2025 under traditional 510(k) K254201 as substantially equivalent to predicate devices.
- Product code EMA places it under 21 CFR 872.3275, confirming it is a resin-based dental cement for crowns, bridges, and inlays.
- Cleared for general restorative use; no new clinical data or expanded indications beyond the predicate.
- Mediclus Co., Ltd. is the manufacturer; practices should confirm U.S. distribution channels and availability before ordering.
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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