Invisalign Palatal Expander System
K-Number: K232887 · 2023-12-15
ApplicantAlign Technology, Inc.
Decision Date2023-12-15
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Invisalign Palatal Expander System is a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2023-12-15 under approval number K232887. 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 Palatal Expander System?
Invisalign Palatal Expander System is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Align Technology, Inc.. The 510(k) number is K232887.
When was Invisalign Palatal Expander System approved by the FDA?
Invisalign Palatal Expander System received FDA 510(k) clearance on 2023-12-15, under approval number K232887.
What company makes Invisalign Palatal Expander System?
Invisalign Palatal Expander System is manufactured by Align Technology, Inc..
What is the FDA product code for Invisalign Palatal Expander System?
The FDA product code for Invisalign Palatal Expander System is NXC.
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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.