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metacem meta p bond metacem silane ceramic primer
Meta Biomed
Summary: The Metacem Meta P Bond Metacem Silane Ceramic Primer is a dental adhesive system used primarily by dentists for bonding ceramic restorations. It enhances the adhesion between ceramic materials and tooth structures.
FDA Clearance Information
Pathway
510K
Number
K081913 ↗
Decision Date
September 5, 2008
Product Code
EMA
Device Class
Class 2
Evidence
0 studies
The Metacem Meta P Bond Metacem Silane Ceramic Primer was cleared through the FDA 510(k) pathway on September 5, 2008. Manufactured by Meta Biomed, it is classified as a Class 2 device under product code EMA.
What It Is
The Metacem Meta P Bond Metacem Silane Ceramic Primer is a dental adhesive system designed to improve the bond strength between ceramic restorations and tooth structures. It works by chemically interacting with the ceramic surface and the adhesive resin, creating a durable bond. This system is particularly useful in restorative dentistry for procedures involving ceramic crowns, veneers, and inlays/onlays.
Clinical Applications
This device is commonly used in restorative dental procedures where ceramic materials are involved. Dentists use it in settings such as private practices and dental clinics, primarily for adult patients requiring ceramic restorations. It is particularly beneficial in cosmetic dentistry for ensuring long-lasting results in procedures like crown placement and veneer bonding.
Indications for Use
The FDA-cleared indications for this device include its use as an adhesive primer for bonding ceramic dental restorations. It is suitable for patients requiring enhanced adhesion of ceramic materials to tooth structures, particularly in restorative and cosmetic dental procedures.
Practical Considerations
When using this device, clinicians should ensure proper surface preparation of the ceramic material for optimal bonding. It is compatible with a variety of ceramic types and can be integrated into standard dental adhesive protocols. Proper handling and application techniques are crucial for achieving the desired bond strength.
Frequently Asked Questions
What is Metacem Meta P Bond Metacem Silane Ceramic Primer used for?
It is used as an adhesive system to bond ceramic dental restorations to tooth structures.
What specialties typically use this device?
This device is primarily used by dentists, particularly those specializing in restorative and cosmetic dentistry.
What are the FDA-cleared indications?
The device is indicated for use as an adhesive primer for bonding ceramic dental restorations.
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.