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ultradent product tooth surface drying agent
Ultradent Products
Summary: The Ultradent Product Tooth Surface Drying Agent is a device used primarily for drying tooth surfaces. It is FDA 510k cleared and linked to studies on pain control in dentin hypersensitivity.
FDA Clearance Information
Pathway
510K
Number
K921602 ↗
Decision Date
September 9, 1992
Product Code
EBF
Device Class
Class 2
Evidence
0 studies
The Ultradent Product Tooth Surface Drying Agent was cleared through the FDA 510k pathway on September 9, 1992. It is manufactured by Ultradent Products and classified as a Class 2 device.
What It Is
The Ultradent Product Tooth Surface Drying Agent is designed to dry tooth surfaces effectively, facilitating various dental procedures. It is intended for use in clinical settings by dental professionals.
Clinical Applications
This device is commonly used in dental practices for procedures requiring a dry tooth surface, such as bonding and restorative treatments. It aids in improving the adhesion of dental materials.
Evidence Summary
The available literature includes two studies focusing on pain control in dentin hypersensitivity. These studies are registered on ClinicalTrials.gov, though specific details on sample sizes and outcomes are not provided.
Reported Outcomes
Published studies report a focus on controlling pain due to dentin hypersensitivity in patients with molar-incisor hypomineralization. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include a lack of detailed safety data in the available studies. The studies do not provide specific information on adverse events or complications.
Evidence Limitations
The evidence is limited by the lack of detailed study outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles for the device.
Frequently Asked Questions
What are the clinical indications for Ultradent Product Tooth Surface Drying Agent?
The device is indicated for drying tooth surfaces to aid in dental procedures such as bonding and restorations.
What outcomes have been reported in clinical studies?
The studies focus on pain control in dentin hypersensitivity, but specific outcomes are not detailed.
What complications have been reported?
The available evidence does not provide specific safety data or reported complications.
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.