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interface
Apex Dental Materials
Summary: Interface by Apex Dental Materials is an ablation device for tumor treatment. It is FDA 510k cleared and supported by 15 studies, focusing on interface engineering and material design.
FDA Clearance Information
Pathway
510K
Number
K053103 ↗
Decision Date
February 1, 2006
Product Code
KLE
Device Class
Class 2
Evidence
0 studies
Interface was cleared through the FDA 510k pathway on February 1, 2006. It is manufactured by Apex Dental Materials and classified as a Class 2 device.
What It Is
Interface is a medical device designed for tumor ablation, utilizing advanced interface engineering to enhance its clinical efficacy. It is intended for use in surgical settings to aid in the removal of tumors.
Clinical Applications
Interface is commonly used in oncological surgeries where precise tumor ablation is required. It is particularly useful in scenarios where minimizing postoperative adhesions is critical.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2024 and 2025. These studies focus on interface design and material optimization.
Reported Outcomes
Published studies report advancements in interface design leading to improved device efficiency and effectiveness in tumor ablation. However, specific clinical outcomes related to tumor reduction or patient recovery were not detailed in the provided abstracts.
Safety Profile
Reported complications include potential issues related to interface material interactions, though specific adverse events were not detailed in the provided evidence. Further research is needed to fully understand the safety profile.
Evidence Limitations
The evidence is limited by a lack of detailed clinical outcomes and specific safety data. Further research is needed to explore long-term efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Interface?
Interface is indicated for use in tumor ablation procedures, particularly in settings where minimizing postoperative adhesions is important.
What outcomes have been reported in clinical studies?
Studies have reported advancements in interface design, but specific clinical outcomes related to tumor reduction were not detailed.
What complications have been reported?
Reported complications include potential issues with interface material interactions, though specific adverse events were not detailed.
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.