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EsCem RMGI

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250566

by Spident Co., Ltd.

Identifiers

510(k) Number
K250566 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)

EsCem RMGI is a resin-modified glass ionomer luting cement, classified as a dental cement. It combines the adhesive properties of glass ionomers with the handling characteristics of resin composites, providing a reliable bonding agent for dental restorations. This material is designed to facilitate cementation of indirect restorations, including metal, resin, ceramic, and zirconia-based restorations, ensuring durable fixation in clinical settings.

The device is supplied as a dual-syringe system containing base and catalyst components, intended for single-use in dental procedures. It is not sterile at the point of sale but is intended to be mixed and applied under aseptic conditions in a clinical environment. EsCem RMGI is classified as a Class II medical device under FDA regulations (872.3275) and has received FDA 510(k) clearance (K250566) for dental applications. No MRI safety or reusable specifications are indicated.

Frequently asked questions

What types of dental restorations can EsCem RMGI be used to secure, and why is this combination of materials important?

EsCem RMGI is specifically designed for cementing indirect restorations made from metal, resin, ceramic, and zirconia. This versatility is important because it combines the adhesive properties of traditional glass ionomers with the improved handling and durability of resin composites, ensuring a strong and reliable bond across different restoration materials.

Is EsCem RMGI pre-sterilized, and how should it be handled in a clinical setting to maintain aseptic conditions?

EsCem RMGI is not sterile at the point of sale, so it must be mixed and applied under aseptic conditions in the clinical environment. Since it is intended for single-use, proper sterilization of tools and surfaces, along with careful handling of the dual-syringe system, is essential to prevent contamination during use.

What form does EsCem RMGI come in, and how does this dual-syringe system benefit the user?

EsCem RMGI is supplied as a dual-syringe system, containing separate base and catalyst components. This design allows for precise mixing in a controlled ratio, improving consistency, ease of application, and reducing waste compared to manual mixing methods.

Does EsCem RMGI have any special storage requirements, and how should it be stored before use?

The provided data does not specify storage conditions, but as a dental luting cement, it should generally be stored in a cool, dry place away from direct sunlight and extreme temperatures. Since it is not sterile, it should also be kept in a sealed, contamination-free environment until ready for use.

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: 스피덴트 Spident, EsCem RMGI | Resin-Modified Glass Ionomer Cement | SPIDENT, EsCem RMGI (K250566) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spident Co., Ltd.

Sources (1)

  • FDA 510(k) K250566 24 fields · synced Sep 19, 2026