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Neocis Inc.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
18
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0929-2021Class IIDRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parentOctober 30, 2020
Z-2638-2020Class IIDRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intendeMay 14, 2020
Z-2637-2020Class IIDRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intendeMay 14, 2020
Z-2639-2020Class IIDRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intendedMay 14, 2020
Z-0511-2020Class IINeocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computeOctober 4, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K252376Yomi S Robotic SystemOctober 28, 2025
K251835Yomi Robotic SystemOctober 10, 2025
K231018Yomi Robotic SystemAugust 14, 2023
K222750Yomi Robotic SystemDecember 8, 2022
K222049Yomi Robotic SystemNovember 4, 2022
K211466Yomi Robotic System with YomiPlan GoJune 14, 2022
K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1December 22, 2021
K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayJuly 28, 2021
K203401Neocis Guidance System (NGS) with Patient Splints (EPS)December 15, 2020
K202264Neocis Guidance System (NGS) with Yomi Plan v2.0December 4, 2020
K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)October 19, 2020
K200805Neocis Guidance System (NGS) with Patient SplintsJuly 28, 2020
K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)May 8, 2020
K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsOctober 2, 2019
K191605Neocis Guidance System (NGS)September 11, 2019
K182776Neocis Guidance SystemDecember 21, 2018
K173402Neocis Guidance System (NGS) with Chairside SplintFebruary 22, 2018
K161399Neocis Guidance SystemDecember 22, 2016