iTero Lumina Pro— 510(k) K261847

Substantially Equivalent

Align Technology , Ltd.

FDA 510(k) clearance K261847 for iTero Lumina Pro, Substantially Equivalent on 2026-07-02. Applicant: Align Technology , Ltd.. Device class: 2.

Clearance details

Applicant: Align Technology , Ltd.
Product code: Code NTK
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2026-06-03
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Petach Tikva, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.