FDA Product Code NXC: Aligner, Sequential
The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
Leading manufacturers include Align Technology, Inc., Blue Sky Bio, LLC and Dentsply Sirona, Inc..
FDA 510(k) Cleared Aligner, Sequential Devices (Product Code NXC)
About Product Code NXC - Regulatory Context
510(k) Submission Activity
143 total 510(k) submissions under product code NXC since 1998, with 143 receiving FDA clearance (average review time: 170 days).
Submission volume has declined in recent years - 22 submissions in the last 24 months compared to 33 in the prior period.
FDA Review Time
Recent submissions under NXC have taken an average of 129 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.
NXC devices are reviewed by the Dental panel. Browse all Dental devices →