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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K252538
Device Name CEPHX3D
Applicant
Orca Dental AI , Ltd.
Dolev St. 4
Ra'Anana,  IL 4366204
Applicant Contact Moshe Melamed
Correspondent
Orca Dental AI , Ltd.
Dolev St. 4
Ra'Anana,  IL 4366204
Correspondent Contact Moshe Melamed
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/12/2025
Decision Date 03/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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