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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Navigation System
510(k) Number K222049
Device Name Yomi Robotic System
Applicant
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Applicant Contact Olga Lewis
Correspondent
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Correspondent Contact Olga Lewis
Regulation Number872.4120
Classification Product Code
QRY  
Subsequent Product Code
PLV  
Date Received07/12/2022
Decision Date 11/04/2022
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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