Neocis, Inc.
Neocis, Inc. holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2025, with 5 FDA device recalls on record.
Top product codes for Neocis, Inc.
FDA recalls by Neocis, Inc.
- 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)
- 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.
- 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.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Neocis, Inc.
- K252376 — Yomi S Robotic System
- K251835 — Yomi Robotic System
- K231018 — Yomi Robotic System
- K222750 — Yomi Robotic System
- K222049 — Yomi Robotic System
- K211466 — Yomi Robotic System with YomiPlan Go
- K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1
- K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array
- K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS)
- K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0
- K202100 — Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
- K200805 — Neocis Guidance System (NGS) with Patient Splints
- K200348 — Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
- K191363 — Neocis Planning Software Application (NPSA) for 3rd Party PCs
- K191605 — Neocis Guidance System (NGS)
- K182776 — Neocis Guidance System
- K173402 — Neocis Guidance System (NGS) with Chairside Splint
- K161399 — Neocis Guidance System
Data sourced from openFDA. This site is unofficial and independent of the FDA.