UCLA and Universal Abutments
FDA 510(k)Class II (US FDA 510(k))
by Diamodent
Identifiers
- 510(k) Number
- K010619 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 UCLA and Universal Abutments are dental devices designed to provide a stable foundation for dental restorations. They are used in implant dentistry to connect dental implants to prosthetic components, ensuring proper alignment and function.
These abutments are supplied as sterile, single-use devices and are available in various sizes to accommodate different clinical needs. They must be stored in a controlled environment to maintain sterility and are intended for use by dental professionals. The device has received FDA 510(k) clearance under K010619.
Frequently asked questions
What are UCLA and Universal Abutments used for?
These dental devices serve as a stable foundation for dental restorations. They connect dental implants to prosthetic components, ensuring proper alignment and function.
How are these abutments supplied?
They are supplied as sterile, single-use devices. This means each abutment is intended for use on a single patient and procedure to maintain sterility.
What sizes are available for these abutments?
The device is available in various sizes to accommodate different clinical needs. The specific size options are detailed in the manufacturer's specifications.
How should the abutments be stored?
To maintain sterility, the abutments must be stored in a controlled environment. This ensures the device remains safe for use when it is time to deploy it.
What is the regulatory status of these abutments?
The UCLA and Universal Abutments have received FDA 510(k) clearance under K010619. This indicates they have been reviewed and determined to be substantially equivalent to a predicate device.
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: UCLA AND UNIVERSAL ABUTMENTS (K010619) — FDA 510(k) | Innolitics, UCLA/UNIVERSAL ABUTMENT (K993129) — FDA 510(k) | Innolitics, Ucla/Universal Abutment - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010619 | Class II | Active |
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Manufacturer
- Manufacturer
- Diamodent
Sources (1)
- FDA 510(k) K010619 24 fields · synced Sep 25, 2026