Cleared Special

K261847 - iTero Lumina™ Pro

K261847 is an FDA 510(k) clearance for iTero Lumina Pro, manufactured by Align Technology , Ltd.. The device is a Class 2 Dental device with product code NTK cleared through the Special 510(k) pathway after a 29-day FDA review.

K261847 · Align Technology , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
29d
Days
Class 2
Risk

K261847 is an FDA 510(k) clearance for the iTero Lumina™ Pro. Classified as Caries Detector, Laser Light, Transmission (product code NTK), Class II - Special Controls.

Submitted by Align Technology , Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on July 2, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K261847

510(k) Number K261847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2026
Decision Date July 02, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

NTK Device Classification - Class 2, Special Controls

Product Code NTK Caries Detector, Laser Light, Transmission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NTK Caries Detector, Laser Light, Transmission

All 11
Devices cleared under the same product code (NTK) and FDA review panel - the closest regulatory comparables to K261847.
Primescan 2
K250771 · Dentsply Sirona, Inc. · Aug 2025
iTero Lumina™ Pro
K240573 · Align Technology , Ltd. · Aug 2024
TIA Tip, Cariosity, Transillumination Accessory Tip
K213482 · D4D Technologies, LLC · Apr 2022
iTero Element 5D
K193659 · Align Technology, Inc. · Mar 2020
DEXIS CariVu 3-in-1 by KaVo
K182712 · Kaltenbach & Voigt GmbH · Nov 2019
CamX Triton HD Proxi Head
K172007 · Duerr Dental AG · Nov 2017
K261847 · iTero Lumina™ Pro
Download PDF FDA Summary Align Technology , Lt…