Elos Accurate Customized Abutment, Elos Prosthetic Screw
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171799 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 Elos Accurate Customized Abutment and Elos Prosthetic Screw are dental devices designed for use in prosthetic restorations. These components are engineered to support the connection between a dental implant and a final restoration.
This device is supplied by Elos Medtech Pinol A/S and has received FDA 510K clearance. It is classified under product code NHA and is intended for use in dental clinical settings.
Frequently asked questions
What is the primary function of the Elos Accurate Customized Abutment and Prosthetic Screw?
These dental components are engineered to provide a secure connection between a dental implant and the final prosthetic restoration, ensuring structural support for the patient's dental work.
Who is the manufacturer of these dental prosthetic components?
The Elos Accurate Customized Abutment and Elos Prosthetic Screw are manufactured by Elos Medtech Pinol A/S, located in Goerloese, Denmark.
What is the regulatory status of this device?
This device has received FDA 510K clearance under K-number K171799. It is classified under product code NHA and has been determined to be substantially equivalent to existing devices for use in dental clinical settings.
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 | K171799 | Class II | Active |
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Manufacturer
- Manufacturer
- Elos Medtech Pinol A/S
Sources (1)
- FDA 510(k) K171799 24 fields · synced Sep 23, 2026