Invisalign System
K-Number: K252380 · 2025-08-29
ApplicantAlign Technology, Inc.
Decision Date2025-08-29
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Invisalign System is a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2025-08-29 under approval number K252380. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Invisalign System?
Invisalign System is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Align Technology, Inc.. The 510(k) number is K252380.
When was Invisalign System approved by the FDA?
Invisalign System received FDA 510(k) clearance on 2025-08-29, under approval number K252380.
What company makes Invisalign System?
Invisalign System is manufactured by Align Technology, Inc..
What is the FDA product code for Invisalign System?
The FDA product code for Invisalign System is NXC.
Related Clinical Trials
Other Devices by Align Technology, Inc.
Related Devices (Code: NXC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.