NOMAD Pro 3— 510(k) K253864

Substantially Equivalent

Dental Imaging Technologies Corporation

FDA 510(k) clearance K253864 for NOMAD Pro 3, Substantially Equivalent on 2026-03-20. Applicant: Dental Imaging Technologies Corporation. Device class: 2.

Summary

Dental Imaging Technologies' NOMAD Pro 3 is filed under EHD, extraoral x-ray units with timer. The record doesn't describe the unit beyond its name and that code name.

Class II, 21 CFR 872.1800. The Radiology review panel handled it as a Traditional 510(k), though the record lists Dental as the classification panel.

Dental Imaging Technologies filed from Quakertown, Pennsylvania. Review took 107 calendar days (December 3, 2025 to March 20, 2026).

Clearance details

Applicant
Dental Imaging Technologies Corporation
Product code
Product code EHD
Device class
Class 2
Regulation
21 CFR 872.1800
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Quakertown, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.