← Back to catalogue

Neocis Guidance System (NGS) with Patient Splints

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200805

by Neocis Inc

Identifiers

510(k) Number
K200805 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 Patient Splints is a Dental Stereotaxic Instrument intended to provide assistance in both the planning (pre-operative) and the surgical (in-operative) phases of dental procedures. It is a computerized navigational system designed to support accurate instrument guidance during oral and maxillofacial surgery.

The device is supplied as a reusable system with patient-specific splints, intended for use in clinical dental settings. It is classified as a Class II medical device under FDA regulation 872.4120, with product code PLV, and received traditional 510(k) clearance (K200805) on July 28, 2020, based on substantial equivalence to a predicate device.

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 Patient Splints (K200805) — FDA 510 ..., Neocis Guidance System (NGS) with Patient Splints… - FDA.report, K200805 FDA 510(k) - Neocis Guidance System (NGS) with Patie...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Neocis Inc
FDA Applicant
Neocis, Inc.

Sources (1)

  • FDA 510(k) K200805 24 fields · synced Sep 22, 2026