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opaque coating surface stain
Dentsply Intl.
Summary: The opaque coating surface stain by Dentsply Intl. is a device cleared by the FDA for clinical use. It is primarily used in tumor ablation procedures. Key evidence highlights its application in enhancing cell adhesion and promoting osteogenic differentiation.
FDA Clearance Information
Pathway
510K
Number
K840751 ↗
Decision Date
May 11, 1984
Product Code
EBD
Device Class
Class 2
Evidence
0 studies
The opaque coating surface stain was cleared by the FDA via the 510k pathway on May 11, 1984. It is manufactured by Dentsply Intl. and classified as a Class 2 device.
What It Is
The opaque coating surface stain is a medical device used in clinical settings for tumor ablation. It functions by providing a surface that enhances cell adhesion and promotes specific cellular behaviors, such as osteogenic differentiation.
Clinical Applications
This device is commonly used in procedures requiring enhanced cell adhesion and differentiation, such as in dental implants and tissue engineering. It is particularly useful in scenarios where osseointegration is critical.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and case series, published between 2008 and 2024. These studies explore the device's efficacy in promoting cell behavior and its mechanical properties.
Reported Outcomes
Published studies report that the opaque coating surface stain enhances osteogenic differentiation and cell adhesion. It has been shown to facilitate the observation of osteoblast migration and improve osseointegration in dental applications.
Safety Profile
Reported complications include challenges in applying the coating under practical conditions due to its opaqueness and mechanical wear-resistant properties. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale RCTs and long-term follow-up studies. Further research is needed to explore the device's full potential and address the mechanical challenges reported.
Frequently Asked Questions
What are the clinical indications for opaque coating surface stain?
The device is indicated for use in tumor ablation and procedures requiring enhanced cell adhesion and differentiation.
What outcomes have been reported in clinical studies?
Studies report enhanced osteogenic differentiation and improved cell adhesion, particularly in dental and tissue engineering applications.
What complications have been reported?
Reported complications include difficulties with opaqueness and mechanical wear resistance, 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.