Neocis Planning Software Application (NPSA) for 3rd Party PCs
FDA 510(k)Class II (US FDA 510(k))
by Neocis Inc
Identifiers
- 510(k) Number
- K191363 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 Planning Software Application (NPSA) for 3rd Party PCs is a dental stereotaxic instrument designed to perform the planning phase of dental implantation surgery. This software application provides pre-operative planning for dental implantation procedures.
The device is supplied for use on third-party PCs and is classified as a Class II device with special controls under regulation number 872.4120. It is intended for dental use and was cleared by the FDA on 2019-10-02 under 510(k) number K191363 with a substantially equivalent determination.
Frequently asked questions
What is the Neocis Planning Software Application used for?
The Neocis Planning Software Application is used for pre-operative planning of dental implantation procedures, providing a planning phase for dental implantation surgery.
What type of device is the NPSA classified as?
The NPSA is classified as a Class II device with special controls under regulation number 872.4120, intended for dental use.
Is the NPSA supplied with its own PC or for use on third-party PCs?
The NPSA is supplied for use on third-party PCs, allowing for flexibility in its deployment.
What is the regulatory status of the NPSA?
The NPSA was cleared by the FDA on 2019-10-02 under 510(k) number K191363 with a substantially equivalent determination.
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 Planning Software Application (NPSA) for 3rd Party PCs, K191363 - Neocis Planning Software Application (N... | FDA 510(k), Neocis Planning Software Application (NPSA) For 3rd Party PCs 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 | K191363 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocis Inc
- FDA Applicant
- Neocis, Inc.
Sources (1)
- FDA 510(k) K191363 24 fields · synced Sep 21, 2026