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atlantis abutment for nobel replace interface
Atlantis Components
Summary: The Atlantis Abutment for Nobel Replace Interface is a custom CAD/CAM abutment designed for dental implants. It is primarily used to improve implant stability and aesthetics. Key evidence highlights its mechanical resistance and marginal accuracy.
FDA Clearance Information
Pathway
510K
Number
K053654 ↗
Decision Date
July 31, 2006
Product Code
NHA
Device Class
Class 2
Evidence
0 studies
The Atlantis Abutment for Nobel Replace Interface was cleared through the FDA 510(k) pathway on July 31, 2006. It is manufactured by Atlantis Components and classified as a Class 2 medical device.
What It Is
The Atlantis Abutment is a custom CAD/CAM abutment designed for use with Nobel Replace dental implants. It serves to enhance the stability and aesthetic outcome of dental implants by providing a precise fit and customizable design.
Clinical Applications
Commonly used in restorative dentistry, the Atlantis Abutment is applied in scenarios requiring improved implant stability and aesthetic outcomes. It is particularly useful in cases where custom abutments are needed to accommodate unique patient anatomy.
Evidence Summary
The available literature includes three studies, comprising retrospective and in vitro analyses, published between 2012 and 2021. These studies evaluate mechanical resistance, marginal accuracy, and clinical outcomes of the abutment.
Reported Outcomes
Published studies report that the Atlantis Abutment demonstrates favorable mechanical resistance and marginal accuracy. The retrospective study highlighted satisfactory clinical and prosthetic outcomes over a four-year period. In vitro tests showed comparable performance to original implant-abutment connections.
Safety Profile
Reported complications include potential for microgaps at the implant-abutment interface, which may lead to microbial colonization and peri-implant tissue inflammation. However, no significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of some analyses. Further research is needed to assess long-term outcomes and to compare performance across different implant systems.
Frequently Asked Questions
What are the clinical indications for Atlantis Abutment for Nobel Replace Interface?
The Atlantis Abutment is indicated for use in dental implant procedures requiring custom abutments to enhance stability and aesthetics.
What outcomes have been reported in clinical studies?
Studies report favorable mechanical resistance, marginal accuracy, and satisfactory clinical outcomes over a four-year period.
What complications have been reported?
Reported complications include potential microgaps leading to microbial colonization and peri-implant tissue inflammation.
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.