Identifiers
- 510(k) Number
- K253341 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)
Custom Abutments AS are dental devices designed to provide a precise fit for dental implants, ensuring optimal support for prosthetic restorations. They are manufactured by Medentika GmbH and are intended for use in dental applications to enhance the stability and functionality of dental implants.
The device is supplied as a single-use item and is not reusable. It is intended for use by dental professionals and must be handled according to the manufacturer's instructions. Custom Abutments AS are not MRI-safe and should be stored in a dry, controlled environment to maintain their integrity. The device has received FDA 510(k) clearance, indicating it has been reviewed and deemed substantially equivalent to predicate devices.
Frequently asked questions
What is the Custom Abutments AS used for?
It is a dental device designed to provide a precise fit for dental implants, ensuring optimal support for prosthetic restorations and enhancing the stability and functionality of the implant.
Is the Custom Abutments AS reusable?
No, the device is supplied as a single-use item and is not intended for reuse. It must be handled according to the manufacturer's instructions.
How should the Custom Abutments AS be stored?
The device should be stored in a dry, controlled environment to maintain its integrity and ensure proper performance.
Is the Custom Abutments AS MRI-safe?
No, the Custom Abutments AS is not MRI-safe and should not be exposed to MRI environments.
What is the regulatory status of the Custom Abutments AS?
The device has received FDA 510(k) clearance, indicating it has been reviewed and deemed substantially equivalent to predicate devices.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253341 | Class II | Active |
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Manufacturer
- Manufacturer
- Medentika GmbH
Sources (1)
- FDA 510(k) K253341 24 fields · synced Sep 23, 2026