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osstell mentor rfa
Integration Diagnostics
Summary: The Osstell Mentor RFA is a device used to measure dental implant stability through resonance frequency analysis. It is primarily used to assess osseointegration in dental implants. Key evidence highlights its reliability in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K033689 ↗
Decision Date
February 26, 2004
Product Code
EKX
Device Class
Class 1
Evidence
0 studies
The Osstell Mentor RFA was cleared by the FDA via the 510(k) pathway on February 26, 2004. Manufactured by Integration Diagnostics, it is classified as a Class 1 device under product code EKX.
What It Is
The Osstell Mentor RFA is a resonance frequency analysis device designed to measure the stability of dental implants. It provides clinicians with an objective assessment of implant osseointegration, aiding in treatment planning and monitoring.
Clinical Applications
Commonly used in dental implantology, the Osstell Mentor RFA helps determine the optimal time for loading implants by assessing their stability. It is particularly useful in cases involving complex implant placements or patients with compromised bone quality.
Evidence Summary
The literature includes 15 studies ranging from 2015 to 2025, encompassing various study types such as RCTs and prospective analyses. These studies collectively evaluate the accuracy, reliability, and clinical utility of the device.
Reported Outcomes
Published studies report that the Osstell Mentor RFA provides reliable measurements of implant stability, which correlate well with successful osseointegration. The device has been shown to be effective in both standard and complex clinical scenarios, including patients with a history of radiotherapy.
Safety Profile
Reported complications include potential variability in measurements due to differences in implant types and patient bone quality. However, no significant adverse events directly related to the device's use have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize measurement protocols and explore the device's utility in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Osstell Mentor RFA?
The Osstell Mentor RFA is indicated for assessing the stability of dental implants and monitoring osseointegration, particularly in complex cases or patients with compromised bone quality.
What outcomes have been reported in clinical studies?
Studies have reported reliable and accurate measurements of implant stability, correlating with successful osseointegration and aiding in treatment planning.
What complications have been reported?
Reported complications include variability in measurements due to implant and patient factors, but no significant adverse events directly related to the device have been documented.
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.