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ultrasonic tips with diamond coating
Sybron Endo/Analytic
Summary: Ultrasonic tips with diamond coating are used in dental procedures for enhanced cutting efficiency. Key evidence highlights their effectiveness in reducing micro-leakage and improving fatigue resistance.
FDA Clearance Information
Pathway
510K
Number
K021253 ↗
Decision Date
July 5, 2002
Product Code
ELC
Device Class
Class 2
Evidence
0 studies
The ultrasonic tips with diamond coating by Sybron Endo/Analytic were cleared via the FDA 510(k) pathway on July 5, 2002. They are classified as Class 2 devices under product code ELC.
What It Is
Ultrasonic tips with diamond coating are dental instruments designed to improve cutting efficiency and precision in endodontic procedures. They are intended for use in root-end cavity preparation and fiber post removal.
Clinical Applications
These devices are commonly used in endodontic treatments, particularly for root-end cavity preparation and fiber post removal in endodontically treated teeth. They are favored for their precision and efficiency.
Evidence Summary
The literature includes 12 studies ranging from 2009 to 2023, encompassing various study types such as RCTs and in vitro studies. These studies evaluate the device's cutting efficiency, fatigue resistance, and impact on micro-leakage.
Reported Outcomes
Published studies report that ultrasonic tips with diamond coating improve cutting efficiency and reduce micro-leakage in root-end fillings. They also enhance fatigue resistance compared to non-coated tips, contributing to longer device lifespan.
Safety Profile
Reported complications include potential heat generation and microcrack formation in radicular dentin during use. These issues highlight the need for careful handling and appropriate power settings.
Evidence Limitations
Current evidence is limited by the variability in study designs and small sample sizes. Further research is needed to explore long-term clinical outcomes and optimize usage parameters.
Frequently Asked Questions
What are the clinical indications for ultrasonic tips with diamond coating?
They are indicated for use in endodontic procedures, particularly for root-end cavity preparation and fiber post removal.
What outcomes have been reported in clinical studies?
Studies report improved cutting efficiency, reduced micro-leakage, and enhanced fatigue resistance of the tips.
What complications have been reported?
Reported complications include heat generation and microcrack formation in radicular dentin.
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.