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atlantis abutment for straumann interface
Atlantis Components
Summary: The Atlantis Abutment for Straumann Interface is a custom CAD/CAM abutment system used in dental implantology. It is primarily used for prosthetic rehabilitation in dental implants. Key evidence includes a retrospective study evaluating clinical outcomes over four years.
FDA Clearance Information
Pathway
510K
Number
K050052 ↗
Decision Date
March 7, 2005
Product Code
NHA
Device Class
Class 2
Evidence
0 studies
The Atlantis Abutment for Straumann Interface was cleared by the FDA through the 510(k) pathway on March 7, 2005. It is manufactured by Atlantis Components and classified as a Class 2 medical device.
What It Is
The Atlantis Abutment for Straumann Interface is a custom CAD/CAM abutment designed for use with Straumann dental implants. It facilitates prosthetic rehabilitation by providing a tailored fit for individual patient needs, enhancing the stability and aesthetics of dental restorations.
Clinical Applications
This device is commonly used in dental implantology for patients requiring prosthetic rehabilitation. It is particularly useful in cases where a customized fit is necessary to achieve optimal functional and aesthetic outcomes.
Evidence Summary
The available literature includes a retrospective multicenter case series study and an in vitro study, with publication years ranging from 2016 to 2021. These studies focus on clinical outcomes and mechanical properties of the abutment system.
Reported Outcomes
Published studies report that the Atlantis Abutment system demonstrates satisfactory clinical, radiographic, and prosthetic outcomes over a mean service period of four years. The in vitro study highlights the mechanical resistance and fit of the abutment connections, comparing original and non-original components.
Safety Profile
Reported complications include potential mechanical failures and rotational misfit in non-original abutment connections. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the retrospective nature of the primary study and the lack of detailed safety outcomes. Further research is needed to explore long-term clinical efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Atlantis Abutment for Straumann Interface?
The device is indicated for use in dental implantology for prosthetic rehabilitation, particularly when a custom fit is required for optimal outcomes.
What outcomes have been reported in clinical studies?
Clinical studies report satisfactory outcomes in terms of clinical, radiographic, and prosthetic performance over a four-year period.
What complications have been reported?
Reported complications include mechanical failures and rotational misfit, particularly in non-original abutment connections.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.