FDA 510(k) K261987: Reusable SmartPeg
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-practice owners and implantologists gain another FDA-cleared option for reusable resonance-frequency SmartPegs, potentially lowering per-case sensor costs compared with single-use alternatives.
Key points
- Device cleared via 510(k) K261987 as substantially equivalent under traditional pathway.
- Product code EKX (handpiece, direct drive, AC-powered) regulated under 21 CFR 872.4200.
- Reusable design may affect consumables budget for implant stability monitoring workflows.
- OpenFDA record lists Osstell AB as the sponsor; no additional clinical claims beyond equivalence are stated.
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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