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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Stereotaxic Instrument
510(k) Number K252376
Device Name Yomi S Robotic System
Applicant
Neocis, Inc.
545 NW 26th St.
Suite 700
Miami,  FL  33127
Applicant Contact Jorge Fernandes
Correspondent
Neocis, Inc.
545 NW 26th St.
Suite 700
Miami,  FL  33127
Correspondent Contact Jorge Fernandes
Regulation Number872.4120
Classification Product Code
PLV  
Subsequent Product Code
QRY  
Date Received07/30/2025
Decision Date 10/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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