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FDA 510(k)

iTero Lumina™ Pro

K-Number: K261847 · 2026-07-02

ApplicantAlign Technology , Ltd.
Decision Date2026-07-02
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

iTero Lumina™ Pro is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology , Ltd.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261847. 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 2026-07-02. The listed applicant is Align Technology , Ltd.. The 510(k) number is K261847.

When did iTero Lumina™ Pro receive FDA 510(k) clearance?

iTero Lumina™ Pro received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261847.

Who is the listed applicant for iTero Lumina™ Pro?

The FDA 510(k) record lists Align Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iTero Lumina™ Pro?

The FDA product code for iTero Lumina™ Pro is NTK.

Other records listing Align Technology , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NTK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250771Primescan 2Dentsply Sirona, Inc.K240573iTero Lumina™ ProAlign Technology , Ltd.K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLCK193659iTero Element 5DAlign Technology, Inc.K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbHK172007CamX Triton HD Proxi HeadDuerr Dental AG

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.

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