MEDIUMRegulatoryTier 1
FDA 510(k) K260096: Wishbone HAE
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 using animal-source bone-grafting materials now have an additional 510(k)-cleared option, Wishbone HAE, that meets Class II regulatory requirements for intraoral use.
Key points
- Wishbone SA received FDA 510(k) clearance K260096 for a bone-grafting material derived from animal source.
- The device is classified as Class 2 under product code NPM and regulation 872.3930.
- Clearance was granted on the basis of substantial equivalence to a predicate device via the traditional 510(k) pathway.
Who should care
OwnerSpecialist
Read the original on openFDA Dental Devices
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