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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K223816
Device Name Dental CT Scanner AXR
Applicant
Alliage S/A Industrias Medico Odontológica
Rod. Abrão Assed, Km 53+450m
Recreio Anhanguera,  BR 14097-500
Applicant Contact Daniel Camargo
Correspondent
Kamm & Assosciates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/20/2022
Decision Date 04/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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