iTero Lumina™ Pro

FDA 510(k) K240573 · Align Technology , Ltd.

Substantially Equivalent

510(k) numberK240573

Submission

Device name
iTero Lumina™ Pro
Applicant
Align Technology , Ltd.
Petach Tikva, IL
Received
March 1, 2024
Decision date
August 16, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NTK – Light Transmission Caries Detector
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1745
Specialty
Dental

Other 510(k)s with product code NTK

510(k)DeviceApplicantDecision
K261847iTero Lumina™ ProNTK · Special Align Technology , Ltd.07/02/2026SE
K250771Primescan 2NTK · Traditional Dentsply Sirona, Inc.08/29/2025SE
K213482TIA Tip, Cariosity, Transillumination Accessory TipNTK · Traditional D4D Technologies, LLC04/29/2022SE
K193659iTero Element 5DNTK · Traditional Align Technology, Inc.03/20/2020SE
K182712DEXIS CariVu 3-in-1 by KaVoNTK · Traditional Kaltenbach & Voigt GmbH11/23/2019SE
K172007CamX Triton HD Proxi HeadNTK · Traditional Duerr Dental AG11/22/2017SE
K123402DiagnocamNTK · Traditional Kaltenbach & Voigt GmbH09/24/2013SE
K071429TI2200 Transillumination CableNTK · Traditional Kerr Corporation09/10/2007SE
K062961Microlux TransilluminatorNTK · Traditional Addent, Inc.02/08/2007SE
K060080Diagnodent 2190 with Periodontal ProbeNTK · Special Kavo Dental Corporation02/08/2006SE

More from Kavo Dental Corporation

510(k)DeviceDecision
K261847iTero Lumina™ ProNTK · Special 07/02/2026SE
K252931Invisalign® Palatal Expander SystemNXC · Special 10/23/2025SE
K252870Invisalign Specifix Attachment SystemNXC · Special 10/09/2025SE
K252380Invisalign SystemNXC · Special 08/29/2025SE
K241412Invisalign SystemNXC · Special 06/18/2024SE
K232887Invisalign Palatal Expander SystemNXC · Traditional 12/15/2023SE
K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXC · Traditional 09/26/2023SE
K222894Invisalign System, Pre-Formed Attachment SystemNXC · Traditional 12/22/2022SE
K220287Invisalign SystemNXC · Special 04/07/2022SE
K193659iTero Element 5DNTK · Traditional 03/20/2020SE

Questions and answers

When was iTero Lumina™ Pro cleared by the FDA?

iTero Lumina™ Pro (K240573) received a 510(k) decision of Substantially Equivalent on August 16, 2024, 168 days after the submission was received.

What is the product code of K240573?

The FDA product code is NTK – Light Transmission Caries Detector, a Class II (moderate risk) device regulated under 21 CFR 872.1745.