Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
FDA 510(k)Class II (US FDA 510(k))
by Neocis Inc
Identifiers
- 510(k) Number
- K200348 FDA 510(k)
- FDA Product Code
- PLV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4120 FDA 510(k)
- Regulation Number
- 872.4120 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) is a Dental Stereotaxic Instrument (Product Code PLV), designed to assist in dental implant procedures. It integrates software for preoperative planning and intraoperative navigation, enabling precise guidance of surgical instruments during both planning and surgery phases. The system leverages a fiducial array splint to enhance spatial accuracy and alignment in dental stereotaxy applications. This device falls under Class II regulatory classification with special controls for dental use.
The NGS with FAS is supplied as a reusable system, intended for use in dental clinics and oral surgery settings. It requires no specific sterility measures beyond standard surgical hygiene protocols, as it is not single-use. The system is compatible with standard dental imaging and surgical workflows, with no noted MRI safety restrictions. Authorized under FDA 510(k) clearance (K200348), the device adheres to regulatory requirements for dental stereotaxic instruments, ensuring compliance with 872.4120 under the Dental Specialty category.
Frequently asked questions
What is the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) used for?
The Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) is designed specifically for dental implant procedures. It integrates preoperative planning software with intraoperative navigation to provide precise stereotaxic guidance. This ensures accurate alignment and positioning of surgical instruments during both planning and surgery, enhancing the precision of dental implant placement.
How is the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) supplied and what are its sterility requirements?
The NGS with FAS is supplied as a reusable system intended for use in dental clinics and oral surgery settings. Since it is reusable, it does not require single-use sterility measures. Standard surgical hygiene protocols should be followed to maintain cleanliness and prevent contamination between procedures.
Is the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) compatible with MRI environments?
The Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) has no noted MRI safety restrictions, meaning it can be used in environments where MRI compatibility is a consideration. However, always verify compatibility with specific MRI systems and protocols in your facility to ensure safe operation.
What regulatory approval does the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) hold?
The Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) has been authorized under FDA 510(k) clearance with the clearance number K200348. This clearance confirms that the device meets regulatory requirements for dental stereotaxic instruments under the Dental Specialty category, specifically complying with 872.4120.
What types of dental procedures can benefit from using the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)?
The NGS with FAS is primarily designed to assist in dental implant procedures, where precise stereotaxic guidance is critical. By integrating preoperative planning with intraoperative navigation, it helps clinicians achieve accurate alignment and positioning of implants. This system is particularly useful in complex cases requiring high precision, such as guided implant surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS), K200348 FDA 510(k) - Neocis Guidance System (NGS) with Fiduc..., Neocis Guidance System (NGS) With Fiducial Array Splint (FAS) 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200348 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocis Inc
- FDA Applicant
- Neocis, Inc.
Sources (1)
- FDA 510(k) K200348 24 fields · synced Oct 5, 2026