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alpha-dent composite surface sealant
Wallace A. Erickson &
Summary: The alpha-dent composite surface sealant is a dental device used to protect and seal composite restorations. It is primarily used by dental professionals to enhance the longevity and appearance of dental work.
FDA Clearance Information
Pathway
510K
Number
K960165 ↗
Decision Date
March 15, 1996
Product Code
EBF
Device Class
Class 2
Evidence
0 studies
The alpha-dent composite surface sealant received FDA clearance through the 510(k) pathway on March 15, 1996. It is manufactured by Wallace A. Erickson & and is classified as a Class 2 device under product code EBF.
What It Is
The alpha-dent composite surface sealant is a dental material designed to provide a protective coating over composite restorations. It works by forming a thin, durable layer that helps to prevent discoloration and wear of the composite material. This sealant is applied by dental professionals during restorative procedures to enhance the aesthetic and functional outcomes of dental treatments.
Clinical Applications
This device is commonly used in dental practices during procedures involving composite restorations, such as fillings and veneers. It is particularly useful in cosmetic dentistry to maintain the appearance of restorations over time. The sealant is applied in a clinical setting by dentists or dental hygienists to patients of all ages who require composite restorations.
Indications for Use
The FDA indications for this device include its use as a protective coating for composite dental restorations. It is intended for patients who have undergone procedures involving composite materials and require additional protection to extend the life of their dental work.
Practical Considerations
The alpha-dent composite surface sealant is typically available in a liquid form that is easy to apply with a brush or applicator. It is compatible with most composite materials used in dental restorations. Clinicians should ensure the surface is clean and dry before application for optimal adhesion.
Frequently Asked Questions
What is alpha-dent composite surface sealant used for?
It is used to protect and seal composite dental restorations, enhancing their longevity and appearance.
What specialties typically use this device?
This device is primarily used in the field of dentistry, particularly by general dentists and cosmetic dentists.
What are the FDA-cleared indications?
The device is indicated for use as a protective coating for composite dental restorations to prevent wear and discoloration.
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.