DeviceClearance

Product code NTK— Dental

iTero Lumina Pro

Classification name
Light Transmission Caries Detector
Device class
Class 2
Regulation
21 CFR 872.1745
Advisory panel
Dental
Total cleared
12
First cleared
Most recent

Market context for product code NTK

FDA has cleared 12 devices under product code NTK between 2004 and 2026, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NTK

Recent clearances under product code NTK

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