📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use as a customized abutment component with compatible Straumann dental implants.
- For supporting dental prostheses during implant-based prosthetic rehabilitation.
- For use when an individualized abutment shape is needed to support functional and esthetic restoration.
Clinical Applications
- Custom abutment fabrication for a Straumann dental implant.
- Support of an implant-retained single-tooth crown.
- Support of an implant-retained fixed partial denture or bridge when compatible with the implant system.
- Prosthetic rehabilitation requiring a patient-specific emergence profile, angulation, or soft-tissue contour.
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.
Practical Considerations
- Compatibility is limited to the specified Straumann implant interface and the appropriate implant dimensions; the implant model and connection should be verified before ordering.
- The abutment is custom designed from an impression or digital scan and should be checked for seating, margins, occlusion, and soft-tissue contour before final restoration.
- The treating dental professional must follow the manufacturer's instructions for design, laboratory processing, torque, cementation, and final prosthesis placement.
- MRI safety depends on the complete implant and restoration system, including any associated components; the patient should provide the exact implant and abutment information to the MRI facility.
- Poor implant integration, inadequate bone or soft-tissue support, infection, excessive occlusal forces, or incompatible prosthetic components may compromise treatment.
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.