Neocis Guidance System (NGS) With Fiducial Array Splint (FAS)

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 Fiducial Array Splint (fas).

Pre-market Notification Details

Device IDK200348
510k NumberK200348
Device Name:Neocis Guidance System (NGS) With Fiducial Array Splint (FAS)
ClassificationDental Stereotaxic Instrument
Applicant Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami,  FL  33137
ContactThomas E. Claiborne
CorrespondentThomas E. Claiborne
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 Received2020-02-12
Decision Date2020-05-08

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