Identifiers
- 510(k) Number
- K123595 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nexus RMGI Resin-Modified Glass Ionomer Luting Cement is a dental luting agent classified as a Cement, Dental (per FDA nomenclature). It is designed to bond restorative materials to tooth structure, providing mechanical retention and chemical adhesion. RMGI cements combine the advantages of traditional glass ionomers—such as fluoride release and biocompatibility—with the improved mechanical properties of resin-modified materials, ensuring durable luting performance in restorative dentistry.
This product is supplied as a single-use, ready-to-mix system for clinical application in dental settings. It requires no sterilization and is intended for one-time use per package. The cement adheres to both enamel and dentin, offering a tack cure within 2–3 seconds for easier cleanup and improved handling. Compliance with FDA 510(k) clearance (K123595) confirms its regulatory standing under 872.3275 for dental cements. Packages are labeled with specific lot and registration numbers for traceability.
Frequently asked questions
What is the Nexus RMGI Dental Luting Cement used for?
The Nexus RMGI Dental Luting Cement is designed to bond restorative materials—such as crowns, inlays, or onlays—to tooth structure. It combines the benefits of traditional glass ionomers (like fluoride release and biocompatibility) with the mechanical strength of resin-modified materials, ensuring long-lasting retention and chemical adhesion in restorative dentistry.
How is the Nexus RMGI supplied and prepared for use?
The Nexus RMGI is supplied as a single-use, ready-to-mix system, eliminating the need for separate mixing or sterilization. Each package contains pre-portioned components that can be mixed directly in the clinical setting, simplifying workflow and ensuring consistent performance.
Is the Nexus RMGI single-use or reusable?
The Nexus RMGI is explicitly designed for single-use per package. This ensures sterility and prevents cross-contamination, aligning with best practices for dental materials in clinical settings.
How quickly does the Nexus RMGI set, and what does this mean for handling?
The Nexus RMGI achieves a tack cure within 2–3 seconds, which allows for easier cleanup and improved handling during placement. This rapid initial setting helps clinicians work efficiently while maintaining precision in luting procedures.
What regulatory approval does the Nexus RMGI have, and how does this affect its use?
The Nexus RMGI holds FDA 510(k) clearance (K123595) under the classification for dental cements (872.3275), confirming its compliance with U.S. regulatory standards. This clearance ensures the product meets established safety and effectiveness criteria for clinical use in dental luting applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nexus™ RMGI Resin-Modified Glass Ionomer Luting Cement, Nexus™ RMGI Resin-Modified Glass Ionomer Luting Cement, Nexus RMGI Resin-Modified Glass Ionomer Luting Cement from Kerr
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123595 | Class II | Active |
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Manufacturer
- Manufacturer
- Kerr Corporation
Sources (1)
- FDA 510(k) K123595 24 fields · synced Oct 1, 2026