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Glas Ionomer Cement

FDA 510(k)

Class II (US FDA 510(k))

510(k) K841195

by Shofu Dental Corp.

Identifiers

510(k) Number
K841195 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)

Glass Ionomer Cement is a dental restorative material classified as a Cement, Dental, designed to bond to tooth structure and provide durable dental restorations. It functions as a restorative filling material, base cement, or luting agent, offering chemical adhesion to enamel and dentin while releasing fluoride to help prevent secondary caries.

This device is supplied in powder-liquid form for mixing and is intended for single-use in dental settings. It is not sterile as packaged but is typically sterilized by the user through proper mixing and handling procedures. The cement is non-magnetic and MRI-safe, available in various sizes and formulations for different clinical applications, including core build-ups, luting, and base placement. Authorized under FDA 510K clearance (K841195) and regulated under 21 CFR 872.3275, it adheres to dental material standards for restorative and adhesive applications.

Frequently asked questions

What clinical roles can this glass ionomer cement be used for in a dental setting?

This glass ionomer cement is designed for multiple dental applications, including as a restorative filling material, a base cement for protecting dental pulp, or a luting agent to secure dental restorations like crowns or bridges. It bonds chemically to both enamel and dentin, providing durable restorations while releasing fluoride to help prevent secondary caries.

How is this product supplied and prepared for use?

The glass ionomer cement is supplied in a powder-liquid form, requiring mixing by the user before application. It is intended for single-use per package and is not sterile as packaged, meaning the user must ensure proper mixing and handling procedures to prepare it for clinical use.

Is this device safe for use in MRI environments, and why?

Yes, this glass ionomer cement is non-magnetic and classified as MRI-safe, meaning it can be used in patients who require MRI scans without interference or safety concerns from the material itself.

What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

This device was cleared through the FDA’s 510(k) pathway, specifically under a Traditional review (K841195) and classified as Substantially Equivalent (SESE). This means the manufacturer demonstrated that it is as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended dental applications.

Are there different sizes or formulations available for this product, and how might they be used?

Yes, this glass ionomer cement is available in various formulations and sizes, tailored for different clinical needs such as core build-ups, luting, or base placement. The specific formulations address different mechanical and adhesive requirements, ensuring versatility for restorative, adhesive, and protective dental procedures.

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: Glass Ionomers - Shofu USA, GlasIonomer Base Cement - Shofu USA, GlasIonomer Cement CX-Plus - Shofu Dental, GlasIonomer Base Cement (Shofu) - skydentalsupply.com, SHOFU GlasIonomer CX Glass Ionomer Luting Cement (1169) - US Dental Depot

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shofu Dental Corp.

Sources (1)

  • FDA 510(k) K841195 24 fields · synced Sep 19, 2026