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metacem
Meta Biomed
Summary: Metacem is a dental luting cement used for securing dental restorations. It is typically used by dental professionals in restorative procedures.
FDA Clearance Information
Pathway
510K
Number
K171449 ↗
Decision Date
May 15, 2018
Product Code
EMA
Device Class
Class 2
Evidence
0 studies
Metacem was cleared through the FDA 510(k) pathway on May 15, 2018. It is manufactured by Meta Biomed and classified as a Class 2 device under product code EMA.
What It Is
Metacem is a dental luting cement designed for securing crowns, bridges, and other dental restorations. It provides strong adhesion and is formulated to be radiopaque, allowing for easy visualization in radiographic imaging. This feature is crucial for ensuring proper placement and monitoring over time.
Clinical Applications
Metacem is commonly used in dental practices, particularly in restorative dentistry. It is applied during procedures involving the placement of crowns, bridges, inlays, and onlays. The cement is suitable for use in both adult and pediatric populations, depending on the specific dental restoration needs.
Indications for Use
Metacem is indicated for use in securing dental restorations such as crowns and bridges. It is suitable for patients requiring durable and reliable adhesion for their dental prosthetics.
Practical Considerations
Metacem is available in various viscosities to accommodate different clinical techniques. It is compatible with a range of dental materials and should be handled according to standard dental cement protocols to ensure optimal results.
Related Literature
The study titled 'Evaluation of the radiopacity of luting cements by digital radiography' assessed the radiopacity of eight luting cements, including Metacem, using digital radiography. The study found that Metacem exhibited sufficient radiopacity, making it easily detectable in radiographic images. However, the study was limited by its focus on radiopacity alone, without evaluating other clinical performance aspects.
Frequently Asked Questions
What is Metacem used for?
Metacem is used for securing dental restorations such as crowns and bridges.
What specialties typically use this device?
Metacem is primarily used in restorative dentistry.
What are the FDA-cleared indications?
Metacem is indicated for use in securing dental restorations, including crowns and bridges.
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.