📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Securing dental restorations such as crowns and bridges
- Luting fixed dental prosthetic restorations to prepared teeth
Clinical Applications
- Cementation of dental crowns
- Cementation of dental bridges
- Cementation of dental inlays
- Cementation of dental onlays
Practical Considerations
- Use the cement according to the manufacturer’s instructions, including the specified mixing, working, and setting times.
- The appropriate cement consistency or viscosity depends on the restoration and the dentist’s clinical technique.
- Compatibility should be confirmed with the restorative material and the tooth surface before use.
- Radiopacity permits assessment of the cement on dental radiographs.
- Contraindications, precautions, and handling requirements should be checked in the current product labeling; this is a dental cement and is not an implantable vascular or intravascular device.
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.