Yomi Robotic System

Dental Navigation System

Neocis Inc.

The following data is part of a premarket notification filed by Neocis Inc. with the FDA for Yomi Robotic System.

Pre-market Notification Details

Device IDK222049
510k NumberK222049
Device Name:Yomi Robotic System
ClassificationDental Navigation System
Applicant Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami,  FL  33137
ContactOlga Lewis
CorrespondentOlga Lewis
Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami,  FL  33137
Product CodeQRY  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-12
Decision Date2022-11-04

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