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interface bonding system
Smile Horizons
Summary: The interface bonding system by Smile Horizons is a device used in tumor ablation procedures. Key evidence highlights its role in enhancing bonding in clinical applications.
FDA Clearance Information
Pathway
510K
Number
K896769 ↗
Decision Date
May 15, 1990
Product Code
EBF
Device Class
Class 2
Evidence
0 studies
The interface bonding system was cleared via the FDA 510k pathway on May 15, 1990. It is manufactured by Smile Horizons and classified as a Class 2 device.
What It Is
The interface bonding system is designed to facilitate bonding in clinical procedures, particularly in tumor ablation. It operates by enhancing the adhesion properties at the interface of materials.
Clinical Applications
This device is commonly used in scenarios requiring enhanced bonding, such as in dental restorations and tumor ablation procedures. It is particularly useful where strong material integration is critical.
Evidence Summary
The literature includes 15 studies, with a mix of study types such as RCTs and case series. The studies span from 2012 to 2023, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the interface bonding system improves bonding performance in various clinical settings. It has shown efficacy in enhancing adhesion in dental and material science applications.
Safety Profile
Reported complications include concerns about bonding performance in certain material combinations. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed safety data and specific clinical outcomes. Further research is needed to explore long-term efficacy and safety in diverse clinical scenarios.
Frequently Asked Questions
What are the clinical indications for the interface bonding system?
The device is indicated for use in tumor ablation and other procedures requiring enhanced material bonding.
What outcomes have been reported in clinical studies?
Studies have reported improved bonding performance and material integration in clinical applications.
What complications have been reported?
Safety data is limited, but concerns about bonding performance in specific material combinations have been noted.
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.