Fas Aligner System
K-Number: K242929 · 2024-12-20
ApplicantXplora 3D Europe S.L
Decision Date2024-12-20
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Fas Aligner System is a medical device manufactured by Xplora 3D Europe S.L. It received FDA 510(k) clearance on 2024-12-20 under approval number K242929. 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 Fas Aligner System?
Fas Aligner System is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Xplora 3D Europe S.L. The 510(k) number is K242929.
When was Fas Aligner System approved by the FDA?
Fas Aligner System received FDA 510(k) clearance on 2024-12-20, under approval number K242929.
What company makes Fas Aligner System?
Fas Aligner System is manufactured by Xplora 3D Europe S.L.
What is the FDA product code for Fas Aligner System?
The FDA product code for Fas Aligner System is NXC.
Related Clinical Trials
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.