Zenex FreeMilling & CCM Cast Abutment
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231557 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 Zenex FreeMilling & CCM Cast Abutment is a dental implant abutment designed for use in fixed prosthodontics. It serves as a connector between dental implants and prosthetic crowns, enabling precise restoration of natural tooth function and aesthetics through custom milling or casting techniques.
This abutment is supplied as a reusable component for dental laboratories and clinicians, intended for use in non-sterile environments prior to sterilisation. It is classified under the product code NHA and has received FDA 510(k) clearance and MDD authorisation, adhering to dental regulatory standards. The device is available in various sizes and configurations to accommodate different implant systems and prosthetic needs.
Frequently asked questions
What types of dental procedures is the Zenex FreeMilling & CCM Cast Abutment designed to support, and how does it connect to prosthetic crowns?
The Zenex FreeMilling & CCM Cast Abutment is specifically designed for fixed prosthodontics, serving as a critical connector between dental implants and prosthetic crowns. It enables precise restoration of both natural tooth function and aesthetics by allowing customization through milling or casting techniques. This versatility makes it suitable for creating tailored restorations that fit individual patient needs.
Is the Zenex FreeMilling & CCM Cast Abutment intended for single-use or reusable applications, and how should it be handled before use?
The Zenex FreeMilling & CCM Cast Abutment is supplied as a reusable component for dental laboratories and clinicians. It is intended for use in non-sterile environments prior to sterilization, meaning it must be properly sterilized before clinical application to ensure safety and efficacy.
What sizes and configurations are available for the Zenex FreeMilling & CCM Cast Abutment, and how does this accommodate different patient needs?
The Zenex FreeMilling & CCM Cast Abutment comes in various sizes and configurations to match different implant systems and prosthetic requirements. This range ensures compatibility with a broad spectrum of clinical scenarios, allowing for customized solutions tailored to specific patient anatomy and treatment plans.
What regulatory pathways has the Zenex FreeMilling & CCM Cast Abutment followed, and what does this mean for its use in clinical settings?
The device has received FDA 510(k) clearance and MDD authorization, adhering to dental regulatory standards. This means it has undergone evaluation to demonstrate substantial equivalence to legally marketed predicate devices and complies with the essential requirements of the Medical Device Directive, ensuring its safety, performance, and suitability for clinical use in fixed prosthodontics.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231557 | Class II | Active |
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Manufacturer
- Manufacturer
- Izenimplant Co., Ltd.
Sources (2)
- FDA 510(k) K231557 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026