Identifiers
- 510(k) Number
- K181580 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cortex Cad/Cam Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. They include titanium abutment blanks with a pre-machined implant connection. The abutments are used in dental applications to support prosthetic restorations. They are a type of endosseous dental implant abutment, classified as a Class II device. The product code for these abutments is NHA.
The Cortex Cad/Cam Abutments are supplied with FDA 510K clearance, indicated by the k number K181580. They are regulated under 21 CFR 872.3630. The abutments are designed for use in dental settings, specifically for supporting dental prosthetic restorations on dental implants. The manufacturer, Cortex Dental Implants Industries Ltd, is based in Shlomi, Israel.
Frequently asked questions
What are Cortex CAD/CAM Abutments used for?
They are used to support dental prosthetic restorations on dental implants, providing a connection between the implant and the prosthetic tooth.
What material are the abutments made of?
The abutments are made of titanium, with pre-machined implant connections for secure fitting.
Are the Cortex CAD/CAM Abutments supplied sterile?
The description does not specify sterility, but they are designed for use in dental settings, implying proper handling and preparation are necessary before use.
What is the regulatory classification of the Cortex CAD/CAM Abutments?
They are classified as a Class II device, regulated under 21 CFR 872.3630, with FDA 510K clearance indicated by the k number K181580.
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: Cortex CAD/CAM Abutments by Cortex Dental Implants Industries Ltd ..., K181580 - Cortex CAD/CAM Abutments - Dental, Cortex CAD/CAM Abutments (K181580) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181580 | Class II | Active |
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Manufacturer
- Manufacturer
- Cortex Dental Implants Industries Ltd.
- FDA Applicant
- Cortex Dental Implants Industries , Ltd.
Sources (1)
- FDA 510(k) K181580 24 fields · synced Oct 6, 2026