Neocis Inc.
Miami, FL, US
NEOCIS INC appears in FDA device records in Miami, FL. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Neocis Inc. between 2016 and 2025. The busiest year on record is 2020, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252376 | Yomi S Robotic System | PLV | Substantially Equivalent | |
| K251835 | Yomi Robotic System | PLV | Substantially Equivalent | |
| K231018 | Yomi Robotic System | PLV | Substantially Equivalent | |
| K222750 | Yomi Robotic System | QRY | Substantially Equivalent | |
| K222049 | Yomi Robotic System | QRY | Substantially Equivalent | |
| K211466 | Yomi Robotic System with YomiPlan Go | PLV | Substantially Equivalent | |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | PLV | Substantially Equivalent | |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | PLV | Substantially Equivalent | |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | PLV | Substantially Equivalent | |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | PLV | Substantially Equivalent | |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | PLV | Substantially Equivalent | |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | PLV | Substantially Equivalent | |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | PLV | Substantially Equivalent | |
| K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | PLV | Substantially Equivalent | |
| K191605 | Neocis Guidance System (NGS) | PLV | Substantially Equivalent | |
| K182776 | Neocis Guidance System | PLV | Substantially Equivalent | |
| K173402 | Neocis Guidance System (NGS) with Chairside Splint | PLV | Substantially Equivalent | |
| K161399 | Neocis Guidance System | PLV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012787974 | 3012787974 | NEOCIS INC | 545 NW 26th St, Miami, FL 33127 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0929-2021 | DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS) | The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. | Class II | Terminated | |
| Z-2639-2020 | DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Terminated | |
| Z-2638-2020 | DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Terminated | |
| Z-2637-2020 | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Terminated | |
| Z-0511-2020 | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers. | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain