MEDIUMRegulatoryTier 1
FDA 510(k) K262196: Invisalign System
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
Orthodontic practices and DSOs that use or plan to use Invisalign clear aligners should note that the FDA has cleared an updated version of the Invisalign System software under product code PNN, confirming it meets Class II regulatory standards.
Key points
- Device cleared under 510(k) K262196 via the Traditional pathway, indicating substantial equivalence to a prior predicate.
- Regulation 872.5470 governs the device; product code PNN is specific to orthodontic software.
- Align Technology, Inc. is the manufacturer; clearance applies to the Invisalign System.
- Class II designation means the software is subject to FDA's general and special controls for safety and effectiveness.
Who should care
OwnerSpecialistDSO
Read the original on openFDA Dental Devices
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