Neocis, Inc.
FDA Regulatory Profile
Neocis, Inc. appears in FDA public data with 5 recalls, 18 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0929-2021, Class II) was initiated on October 30, 2020. Its most recent 510(k) clearance was granted on October 28, 2025.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 18
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0929-2021 | Class II | DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent | October 30, 2020 |
| Z-2638-2020 | Class II | DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intende | May 14, 2020 |
| Z-2637-2020 | Class II | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intende | May 14, 2020 |
| Z-2639-2020 | Class II | DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended | May 14, 2020 |
| Z-0511-2020 | Class II | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a compute | October 4, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252376 | Yomi S Robotic System | October 28, 2025 |
| K251835 | Yomi Robotic System | October 10, 2025 |
| K231018 | Yomi Robotic System | August 14, 2023 |
| K222750 | Yomi Robotic System | December 8, 2022 |
| K222049 | Yomi Robotic System | November 4, 2022 |
| K211466 | Yomi Robotic System with YomiPlan Go | June 14, 2022 |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | December 22, 2021 |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | July 28, 2021 |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | December 15, 2020 |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | December 4, 2020 |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | October 19, 2020 |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | July 28, 2020 |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | May 8, 2020 |
| K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | October 2, 2019 |
| K191605 | Neocis Guidance System (NGS) | September 11, 2019 |
| K182776 | Neocis Guidance System | December 21, 2018 |
| K173402 | Neocis Guidance System (NGS) with Chairside Splint | February 22, 2018 |
| K161399 | Neocis Guidance System | December 22, 2016 |