Neocis Guidance System (NGS) With Yomi Plan V2.0.1

Dental Stereotaxic Instrument

Neocis Inc.

The following data is part of a premarket notification filed by Neocis Inc. with the FDA for Neocis Guidance System (ngs) With Yomi Plan V2.0.1.

Pre-market Notification Details

Device IDK210711
510k NumberK210711
Device Name:Neocis Guidance System (NGS) With Yomi Plan V2.0.1
ClassificationDental Stereotaxic Instrument
Applicant Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami,  FL  33137
ContactDayana Manganese
CorrespondentWilliam Tapia
Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami,  FL  33137
Product CodePLV  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-10
Decision Date2021-12-22

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