đź“Š Evidence-Based Reference
interface - cavity liner
Scientific Pharmaceuticals
Summary: The interface - cavity liner by Scientific Pharmaceuticals is a device used in dental procedures for cavity lining. It is FDA-cleared and linked to 11 studies, focusing on its application in dental restorations.
FDA Clearance Information
Pathway
510K
Number
K897130 ↗
Decision Date
March 27, 1990
Product Code
EJK
Device Class
Class 2
Evidence
0 studies
The interface - cavity liner was cleared through the FDA 510(k) pathway on March 27, 1990. It is manufactured by Scientific Pharmaceuticals and classified as a Class 2 device.
What It Is
The interface - cavity liner is designed for use in dental procedures as a cavity liner. It serves to protect the pulp and provide a barrier under restorative materials, enhancing the longevity and effectiveness of dental restorations.
Clinical Applications
Commonly used in dental restorations, the interface - cavity liner is applied in scenarios requiring pulp protection and cavity lining, particularly in indirect pulp capping and class-II restorations.
Evidence Summary
The literature includes 11 studies, encompassing various study types such as RCTs and retrospective analyses, conducted between 2020 and 2025. These studies explore the device's efficacy and safety in dental applications.
Reported Outcomes
Published studies report that the interface - cavity liner effectively enhances bond strength to surrounding dentin and improves cavity adaptation when used with resin composites. It is also noted for its role in reducing polymerization shrinkage in bulk-fill composites.
Safety Profile
Reported complications include potential deformation when used in press-fit applications and challenges with magnetic diffusion in composite liners. However, specific adverse events related to dental applications were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale clinical trials and detailed safety data specific to dental applications. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for interface - cavity liner?
The device is indicated for use as a cavity liner in dental restorations, particularly for pulp protection and enhancing bond strength in indirect pulp capping.
What outcomes have been reported in clinical studies?
Studies have reported improved bond strength to dentin and reduced polymerization shrinkage in resin composites when using the interface - cavity liner.
What complications have been reported?
Reported complications include potential deformation in press-fit applications and issues with magnetic diffusion in composite liners, though specific dental-related 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.