📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an adhesive primer for bonding ceramic dental restorations.
- Use to improve adhesion between ceramic materials and tooth structures through an adhesive resin system.
Clinical Applications
- Priming ceramic surfaces before placement of ceramic crowns.
- Priming ceramic surfaces before bonding veneers.
- Priming inlays and onlays before adhesive cementation.
- Use as part of a dental adhesive protocol for bonding ceramic restorations to prepared tooth surfaces.
Practical Considerations
- The ceramic surface should be properly cleaned and prepared according to the ceramic manufacturer's instructions before primer application.
- Compatibility depends on the ceramic material, resin cement, adhesive system, and surface-treatment method; clinicians should follow the product labeling and dental material instructions.
- The primer is intended for professional dental use and should be handled according to the manufacturer's instructions, including precautions for contact with the eyes, skin, and oral tissues.
- This is a dental chemical product, not an implanted device; MRI-specific precautions and device-size measurements generally do not apply.
- Contraindications, limitations, storage requirements, and curing or cementation steps should be confirmed in the current manufacturer labeling.
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.