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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 K233395
Device Name Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
Applicant
Alliage S/A Industrias Médico Odontológica
Rodovia Abrão Assed, Km 53 – Cep 14097-500 –Ribeirão Preto
Sao Paulo,  BR
Applicant Contact Daniel Camargo
Correspondent
Kamm & Assosciates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Kamm Daniel
Regulation Number872.1800
Classification Product Code
EHD  
Date Received10/03/2023
Decision Date 01/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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