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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K230732
Device Name Eagle S/Saevo Slim/D700 Slim
Applicant
Alliage S/A Industrias Medica Odontológico.
Rod. Abrão Assed, Km 53+450m
Recreio Anhanguera,  BR 49935
Applicant Contact Daniel Camargo
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Codes
EHD   MQB  
Date Received03/16/2023
Decision Date 04/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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