Manufacturer registered with FDA
Neocis
Miami, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 19 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 192016–2026
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Neocis currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Stereotaxic InstrumentPLV · Class 2 | — | Maker | Yomi Robotic SystemYomi S Robotic System | 2022 |
| Dental Navigation SystemQRY · Class 2 | — | Maker | Yomi Robotic SystemYomi S Robotic System | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Neocis as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Oct 2026 | K261321 | Yomi S Robotic System | QRY Dental Navigation System |
| 28 Oct 2025 | K252376 | Yomi S Robotic System | PLV Dental Stereotaxic Instrument |
| 10 Oct 2025 | K251835 | Yomi Robotic System | PLV Dental Stereotaxic Instrument |
| 14 Aug 2023 | K231018 | Yomi Robotic System | PLV Dental Stereotaxic Instrument |
| 8 Dec 2022 | K222750 | Yomi Robotic System | QRY Dental Navigation System |
| 4 Nov 2022 | K222049 | Yomi Robotic System | QRY Dental Navigation System |
| 14 Jun 2022 | K211466 | Yomi Robotic System with YomiPlan Go | PLV Dental Stereotaxic Instrument |
| 22 Dec 2021 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | PLV Dental Stereotaxic Instrument |
| 28 Jul 2021 | K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | PLV Dental Stereotaxic Instrument |
| 15 Dec 2020 | K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | PLV Dental Stereotaxic Instrument |
| 4 Dec 2020 | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | PLV Dental Stereotaxic Instrument |
| 19 Oct 2020 | K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | PLV Dental Stereotaxic Instrument |
| 28 Jul 2020 | K200805 | Neocis Guidance System (NGS) with Patient Splints | PLV Dental Stereotaxic Instrument |
| 8 May 2020 | K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | PLV Dental Stereotaxic Instrument |
| 2 Oct 2019 | K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | PLV Dental Stereotaxic Instrument |
| 11 Sep 2019 | K191605 | Neocis Guidance System (NGS) | PLV Dental Stereotaxic Instrument |
| 21 Dec 2018 | K182776 | Neocis Guidance System | PLV Dental Stereotaxic Instrument |
| 22 Feb 2018 | K173402 | Neocis Guidance System (NGS) with Chairside Splint | PLV Dental Stereotaxic Instrument |
| 22 Dec 2016 | K161399 | Neocis Guidance System | PLV Dental Stereotaxic Instrument |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEOCIS INCFDA reg. 3012787974 | Miami, FL, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053750). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.