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Neocis Inc.

FDA Regulatory Profile

Neocis Inc. has 5 FDA recalls, 6 inspections, 19 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Neocis Inc." and its spelling variant "Neocis".

Latest recall
Z-0929-2021 · Class II · Oct 30, 2020
Latest inspection
Jun 28, 2024 · NAI
Latest 510(k)
Oct 13, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls5Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances19Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Neocis Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Neocis Inc.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 3 inspections320222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202230000
202100000
202000040
201910010
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

5 recall records from Oct 4, 2019 to Oct 30, 2020.

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

Recent FDA inspections

6 inspections from Nov 2, 2018 to Jun 28, 2024.

DateSiteProductClassificationFEI
Jun 28, 2024Miami, FLDevicesNo Action Indicated (NAI)3012787974
Aug 11, 2022Miami, FLDevicesNo Action Indicated (NAI)3012787974
Aug 5, 2022Miami, FLDevicesVoluntary Action Indicated (VAI)3012787974
Feb 24, 2022Miami, FLDevicesNo Action Indicated (NAI)3012787974
Dec 11, 2019Miami, FLDevicesVoluntary Action Indicated (VAI)3012787974
Nov 2, 2018Miami, FLDevicesNo Action Indicated (NAI)3012787974
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3012787974Miami, FL6Jun 28, 2024

Recent 510(k) clearances

19 510(k) clearances from Dec 22, 2016 to Oct 13, 2026.

K-NumberDeviceDate
K261321Yomi S Robotic SystemOct 13, 2026
K252376Yomi S Robotic SystemOct 28, 2025
K251835Yomi Robotic SystemOct 10, 2025
K231018Yomi Robotic SystemAug 14, 2023
K222750Yomi Robotic SystemDec 8, 2022
K222049Yomi Robotic SystemNov 4, 2022
K211466Yomi Robotic System with YomiPlan GoJun 14, 2022
K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Dec 22, 2021
K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayJul 28, 2021
K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Dec 15, 2020
K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Dec 4, 2020
K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Oct 19, 2020
K200805Neocis Guidance System (NGS) with Patient SplintsJul 28, 2020
K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)May 8, 2020
K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsOct 2, 2019
K191605Neocis Guidance System (NGS)Sep 11, 2019
K182776Neocis Guidance SystemDec 21, 2018
K173402Neocis Guidance System (NGS) with Chairside SplintFeb 22, 2018
K161399Neocis Guidance SystemDec 22, 2016

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.