510(k) K253864

NOMAD Pro 3 by Dental Imaging Technologies Corporation — Product Code EHD

K253864 is an FDA 510(k) premarket notification submitted by Dental Imaging Technologies Corporation for the device "NOMAD Pro 3". The FDA issued a decision of Substantially Equivalent on March 20, 2026. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Dental Imaging Technologies Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2026
Date Received
December 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type