đź“Š Evidence-Based Reference
atlantis abutment in zirconia for 3i certain interface
Atlantis Components
Summary: The Atlantis Abutment in Zirconia for 3i Certain Interface is a dental implant component designed for esthetic restorations. It is primarily used to support crowns in anterior regions. Key evidence highlights its fracture resistance and esthetic benefits.
FDA Clearance Information
Pathway
510K
Number
K063734 ↗
Decision Date
March 2, 2007
Product Code
NHA
Device Class
Class 2
Evidence
0 studies
The Atlantis Abutment in Zirconia for 3i Certain Interface was cleared by the FDA via the 510(k) pathway on March 2, 2007. It is manufactured by Atlantis Components and classified as a Class 2 device.
What It Is
The device is a zirconia abutment designed for use with 3i Certain dental implants. It serves as a connector between the implant and the crown, providing a durable and esthetic solution for dental restorations.
Clinical Applications
Commonly used in dental implantology, the device is suited for anterior tooth restorations where esthetics are a priority. It is employed in cases requiring customized abutment solutions for improved esthetic outcomes.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials and prospective studies, published between 2018 and 2023. These studies evaluate aspects such as fracture resistance, digital workflow accuracy, and clinical outcomes.
Reported Outcomes
Published studies report that the Atlantis Abutment in Zirconia demonstrates sufficient fracture resistance and stability for supporting implant restorations. The device is noted for its esthetic advantages in anterior regions. Some studies highlight the benefits of CAD/CAM customization in achieving optimal fit and esthetics.
Safety Profile
Reported complications include potential loss of abutment screw torque, particularly in narrow-diameter implants with angled screw channels. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the relatively short observation periods compared to titanium abutments. Further research is needed to assess long-term outcomes and the impact of design modifications by third-party manufacturers.
Frequently Asked Questions
What are the clinical indications for Atlantis Abutment in Zirconia for 3i Certain Interface?
The device is indicated for use in dental implant restorations, particularly in anterior regions where esthetics are critical.
What outcomes have been reported in clinical studies?
Studies report sufficient fracture resistance and esthetic benefits, with CAD/CAM customization enhancing fit and appearance.
What complications have been reported?
Safety data indicate potential loss of abutment screw torque in narrow-diameter implants with angled screw channels.
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.