MEDIUMRegulatoryTier 1
FDA 510(k) K262523: Amber Arte
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 labs and restorative practices can now use a new Class II porcelain powder cleared through the 510(k) pathway.
Key points
- Hass Corp. received FDA clearance for Amber Arte porcelain powder via 510(k) K262523.
- The device is classified as Class 2 under regulation 872.6660 with product code EIH.
- The clearance was granted on a traditional substantially equivalent basis.
- The powder is intended for dental porcelain applications.
Who should care
OwnerSpecialist
Read the original on openFDA Dental Devices
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