510(k) Report

FDA applicant

Neocis, Inc.

Miami, FL19 decisions2016–20265 recalls

FDA records 19 decisions for Neocis, Inc. (Miami, FL) from 2016 to 2026: 19 510(k) clearances. Most are in product codes PLV (Dental Stereotaxic Instrument) and QRY (Dental Navigation System). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 86 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 16 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Neocis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2016: 12018: 22019: 22020: 52021: 22022: 32023: 12025: 22026 (partial year): 1
2016high 5 (2020) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

4in 2020

2019: 12020: 4
2016high 4 (2020) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Neocis, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neocis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PLVDental Stereotaxic Instrument16decisions
  • QRYDental Navigation System3decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 101 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 86 days; 3 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 16 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. · 20183cite it
  • K161399Neocis Guidance SystemNeocis, Inc. · 20163cite it
  • K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 20202cite it
  • K231018Yomi Robotic SystemNeocis, Inc. · 20232cite it
  • K182776Neocis Guidance SystemNeocis, Inc. · 20182cite it
  • K200805Neocis Guidance System (NGS) with Patient SplintsNeocis, Inc. · 20201cites it

What has FDA decided for it lately?

  • K261321Yomi S Robotic SystemNeocis, Inc. · 2026
  • K252376Yomi S Robotic SystemNeocis, Inc. · 2025
  • K251835Yomi Robotic SystemNeocis, Inc. · 2025
  • K231018Yomi Robotic SystemNeocis, Inc. · 2023
  • K222750Yomi Robotic SystemNeocis, Inc. · 2022
  • K222049Yomi Robotic SystemNeocis, Inc. · 2022
  • K211466Yomi Robotic System with YomiPlan GoNeocis, Inc. · 2022
  • K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021

All 19 as Neocis, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K173402DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories…Oct 30, 2020Class II
  • K173402DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product…May 14, 2020Class II
  • K173402DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product…May 14, 2020Class II
  • K173402DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product…May 14, 2020Class II
  • K161399Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS)…Oct 4, 2019Class II