FDA 510(k)

iTero Lumina Pro

K-Number: K240573 · 2024-08-16

Decision Date2024-08-16

Product CodeNTK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

iTero Lumina Pro is a medical device manufactured by Align Technology , Ltd.. It received FDA 510(k) clearance on 2024-08-16 under approval number K240573. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTero Lumina Pro?

iTero Lumina Pro is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by Align Technology , Ltd.. The 510(k) number is K240573.

When was iTero Lumina Pro approved by the FDA?

iTero Lumina Pro received FDA 510(k) clearance on 2024-08-16, under approval number K240573.

What company makes iTero Lumina Pro?

iTero Lumina Pro is manufactured by Align Technology , Ltd..

What is the FDA product code for iTero Lumina Pro?

The FDA product code for iTero Lumina Pro is NTK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.