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FDA 510(k) Applications Submitted by Neocis Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K161399
05/20/2016
Neocis Guidance System
Neocis Inc.
K210711
03/10/2021
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
Neocis Inc.
K231018
04/10/2023
Yomi Robotic System
Neocis Inc.
K222750
09/12/2022
Yomi Robotic System
Neocis Inc.
K222049
07/12/2022
Yomi Robotic System
Neocis Inc.
K191363
05/22/2019
Neocis Planning Software Application (NPSA) for 3rd Party PCs
Neocis Inc.
K202100
07/29/2020
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
Neocis Inc.
K200348
02/12/2020
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Neocis Inc.
K200805
03/27/2020
Neocis Guidance System (NGS) with Patient Splints
Neocis Inc.
K191605
06/17/2019
Neocis Guidance System (NGS)
Neocis Inc.
K202264
08/11/2020
Neocis Guidance System (NGS) with Yomi Plan v2.0
Neocis Inc.
K182776
10/01/2018
Neocis Guidance System
Neocis Inc.
K203401
11/19/2020
Neocis Guidance System (NGS) with Patient Splints (EPS)
Neocis Inc.
K211129
04/16/2021
Neocis Guidance System (NGS) with Intraoral Fiducial Array
Neocis Inc.
K211466
05/11/2021
Yomi Robotic System with YomiPlan Go
Neocis Inc.
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