DIO Steady External Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100100 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DIO Steady External Implant System is an endosseous dental implant designed for surgical placement in the upper and lower jaw arches. It serves as a root-form foundation for attaching single or multiple prosthetic appliances to restore chewing function and oral stability.
This system is intended for use in dental surgical settings and is supplied as a reusable implant component. The device holds an FDA 510(k) clearance under the product code DZE, classified under the Dental advisory committee. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What types of prosthetic appliances can the DIO Steady External Implant System support, and where is it surgically placed in the mouth?
The DIO Steady External Implant System is designed as a root-form foundation for attaching single or multiple prosthetic appliances, such as crowns, bridges, or dentures, to restore chewing function and oral stability. It is surgically placed in either the upper or lower jaw arches, integrating directly into the bone (endosseous) to provide a stable anchor for these restorations.
Is the DIO Steady External Implant System intended for single-use or reusable applications, and how does this affect its clinical workflow?
The system is explicitly described as a reusable implant component, meaning it is intended for multiple surgical placements rather than disposable use. This design allows for cost efficiency in clinical settings and streamlines workflow by reducing the need for single-use implants, though proper cleaning and sterilization protocols must be followed between uses.
What regulatory pathway was followed for FDA clearance of the DIO Steady External Implant System, and which advisory committee reviewed it?
The DIO Steady External Implant System received FDA 510(k) clearance under the product code DZE, classified under the Dental advisory committee (DE). The clearance was granted via a traditional review process and determined the device to be substantially equivalent to a predicate, with a decision date of November 10, 2010. This classification reflects its use as an endosseous dental implant.
Are there any specific storage requirements or considerations mentioned for the DIO Steady External Implant System?
The provided data does not include explicit storage instructions for the DIO Steady External Implant System. However, as a reusable medical device intended for surgical use, it should be stored in a clean, dry environment to prevent contamination. Proper handling and sterilization protocols (e.g., autoclaving or chemical sterilization) will be critical before reuse, though these details are not specified in the available information.
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: DEVICE: DIO STEADY External Implant System (18806195920487), DIO Corporation ETF 6013R DIO STEADY External Implant System, DIO Implant USA - DIO Implant USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100100 | Class II | Active |
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Manufacturer
- Manufacturer
- DIO Corporation
Sources (1)
- FDA 510(k) K100100 24 fields · synced Sep 19, 2026