Cleared Traditional

iTero Lumina? Pro

K240573 · Align Technology , Ltd. · Dental

Aug 2024

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K240573 is an FDA 510(k) clearance for the iTero Lumina? Pro, a Caries Detector, Laser Light, Transmission (Class II — Special Controls, product code NTK), submitted by Align Technology , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on August 16, 2024, 168 days after receiving the submission on March 1, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number	K240573 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2024
Decision Date	August 16, 2024
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF