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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K253864
Device Name NOMAD Pro 3
Applicant
Dental Imaging Technologies Corporation
450 Commerce Dr.
Quakertown,  PA  18951
Applicant Contact Peter Schmidt
Correspondent
Dental Imaging Technologies Corporation
450 Commerce Dr.
Quakertown,  PA  18951
Correspondent Contact Peter Schmidt
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/03/2025
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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