Dental Stereotaxic Instrument
Dental · 21 CFR 872.4120
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
Recent MDR events
85 adverse event reports on file
- YOMI ROBOTIC SYSTEMJul 1, 2026InjuryNeocis Inc.3012787974-2026-80099
- YOMI ROBOTIC SYSTEMJun 23, 2026InjuryNeocis Inc.3012787974-2026-80098
- NEOCIS GUIDANCE SYSTEMSep 19, 2025InjuryNeocis Inc.3012787974-2025-80097
- NEOCIS GUIDANCE SYSTEMSep 19, 2025InjuryNeocis Inc.3012787974-2025-80096
- NEOCIS GUIDANCE SYSTEMSep 19, 2025InjuryNeocis Inc.3012787974-2025-80095
- NEOCIS GUIDANCE SYSTEMSep 19, 2025InjuryNeocis Inc.3012787974-2025-80094
- NEOCIS GUIDANCE SYSTEMJun 16, 2025InjuryNeocis Inc.3012787974-2025-80093
- NEOCIS GUIDANCE SYSTEMJan 10, 2025InjuryNeocis, Inc.3012787974-2025-80092
- NEOCIS GUIDANCE SYSTEMOct 30, 2024InjuryNeocis Inc.3012787974-2024-80091
- NEOCIS GUIDANCE SYSTEMOct 16, 2024InjuryNeocis Inc.3012787974-2024-80089
Event type breakdown
Most-reported manufacturers
Recalls
6 recall events for this product code
- Neocis Inc.TerminatedUnknown
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Z-0511-2020 · View FDA record ↗ - Neocis, Inc.TerminatedUnknown
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.
Z-0929-2021 · View FDA record ↗ - X-NAV Technologies, LLCTerminatedUnknown
X-Guide Surgical Navigation System, X-Clip Bulk Kit
The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3
Z-1391-2016 · View FDA record ↗ - Neocis Inc.TerminatedUnknown
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)
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Z-2637-2020 · View FDA record ↗ - Neocis Inc.TerminatedUnknown
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)
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Z-2638-2020 · View FDA record ↗ - Neocis Inc.TerminatedUnknown
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)
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Z-2639-2020 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
510(k) clearances
23 clearances for this product code
- Neocis, Inc.Oct 28, 2025
K252376 · Yomi S Robotic System
- Neocis, Inc.Oct 10, 2025
K251835 · Yomi Robotic System
- Claronav, Inc.Jul 25, 2024
K233563 · Navident
- Neocis, Inc.Aug 14, 2023
K231018 · Yomi Robotic System
- Claronav, Inc.Jun 27, 2022
K210947 · Navident
- Neocis, Inc.Jun 14, 2022
K211466 · Yomi Robotic System with YomiPlan Go
- Navigate Surgical Technologies, Inc.Feb 22, 2022
K213392 · INLIANT Surgical Navigation System
- Neocis, Inc.Dec 22, 2021
K210711 · Neocis Guidance System (NGS) with Yomi Plan v2.0.1