đź“Š Evidence-Based Reference
Eds Ultrasonic TIPS
Essential Dental Systems
Summary: EDS Ultrasonic Tips are dental devices used for decontaminating implant surfaces. They are primarily used in peri-implantitis treatment. Key evidence highlights their effectiveness in surface decontamination.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K132609 ↗
Decision Date ?
January 22, 2014
Product Code ?
ELC
Device Class ?
Class 2
Evidence ?
0 studies
The EDS Ultrasonic Tips were cleared through the FDA 510(k) pathway on January 22, 2014. Manufactured by Essential Dental Systems, they are classified as Class 2 devices.
What It Is
EDS Ultrasonic Tips are designed for ultrasonic activation in dental procedures, particularly for decontaminating implant surfaces. They utilize ultrasonic vibrations to aid in cleaning and decontamination.
FDA-Cleared Indications
- Use as ultrasonic tips during dental procedures to assist with cleaning and decontamination of dental implant surfaces.
- Use in procedures involving the removal of bacterial biofilm and other contaminants from dental implants.
Clinical Applications
- Ultrasonic decontamination of dental implant surfaces.
- Removal of bacterial biofilm from dental implants during peri-implant disease treatment.
- Removal of surface contaminants from dental implants as part of implant maintenance or treatment.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and in vitro analyses, with publication years ranging from 2024 to 2025. These studies evaluate the effectiveness and safety of ultrasonic tips.
Reported Outcomes
Published studies report that EDS Ultrasonic Tips effectively decontaminate implant surfaces, with varying success compared to other methods. They are noted for their ability to maintain surface integrity while removing contaminants.
Safety Profile
Reported complications include the release of titanium particles during decontamination procedures, which could pose a risk of inflammation. However, no major adverse events have been documented in the studies reviewed.
Evidence Limitations
Current evidence is limited by the small sample sizes and the in vitro nature of many studies. Further research is needed to confirm findings in clinical settings and to explore long-term outcomes.
Practical Considerations
- The tips are intended for use with compatible ultrasonic dental equipment; compatibility should be confirmed before treatment.
- Tip size and shape should be selected according to the implant design, surface access and treatment area.
- Use requires careful technique to avoid unwanted damage to the implant surface or surrounding tissues.
- The FDA record identifies the device as a Class II 510(k)-cleared dental device; it is not an MRI implant or an implanted device.
- Contraindications, sterilization requirements and reuse limitations should be taken from the current manufacturer instructions for use.
Frequently Asked Questions
What are the clinical indications for EDS Ultrasonic Tips?
EDS Ultrasonic Tips are indicated for the decontamination of dental implant surfaces, particularly in the treatment of peri-implantitis.
What outcomes have been reported in clinical studies?
Studies report effective decontamination of implant surfaces with EDS Ultrasonic Tips, maintaining surface integrity while removing contaminants.
What complications have been reported?
Safety data indicate the potential release of titanium particles during use, which could lead to inflammation, but no major adverse events have been reported.
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.