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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 K231018
Device Name Yomi Robotic System
Applicant
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Applicant Contact Joshua Davis
Correspondent
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Correspondent Contact Joshua Davis
Regulation Number872.4120
Classification Product Code
PLV  
Subsequent Product Code
QRY  
Date Received04/10/2023
Decision Date 08/14/2023
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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