📊 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 ?
510(k)
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.
FDA-Cleared Indications
- Use with compatible 3i Certain dental implants as a restorative abutment.
- Support a dental crown or other implant-supported restoration.
- Use when a customized zirconia abutment is selected for the planned dental restoration.
Clinical Applications
- Connecting a compatible 3i Certain implant to an implant-supported crown.
- Supporting anterior tooth restorations where the appearance of the abutment is important.
- Providing a customized emergence profile and restorative connection for an implant crown.
- Use as part of a staged dental implant restoration after placement and integration of the implant.
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.
Practical Considerations
- Compatibility is limited to the specified 3i Certain implant interface; the implant connection should be verified before ordering or placement.
- The abutment is customized to the patient's implant position and planned crown, so accurate impressions or digital scans and laboratory or CAD/CAM planning are required.
- Zirconia is selected primarily for esthetic reasons, but the clinician must evaluate occlusal forces, implant angulation, available restorative space and the planned restoration.
- The abutment should be handled according to the manufacturer's instructions to avoid damage to the zirconia or implant connection.
- MRI safety depends on the complete implant restoration and all implanted components; patients should provide the exact implant and abutment information to the MRI facility for assessment.
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.