← Back to catalogue

Glasionomer Cement CX Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982461

by Shofu Dental Corp.

Identifiers

510(k) Number
K982461 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)

Glasionomer Cement CX Plus is a dental cement used for restorative and luting procedures in dentistry. It is a type of glass ionomer cement that provides adhesion to tooth structure and releases fluoride for caries prevention.

The device is supplied as a single-use product and requires proper storage conditions to maintain its integrity. It is classified as a Class II medical device by the FDA and has received 510(k) clearance for dental applications. The cement is available in various formulations and sizes as specified by the manufacturer.

Frequently asked questions

What is Glasionomer Cement CX Plus used for in dental procedures?

Glasionomer Cement CX Plus is used for both restorative and luting procedures in dentistry. It provides adhesion to tooth structure and releases fluoride for caries prevention, making it suitable for various dental applications.

Is Glasionomer Cement CX Plus a single-use product?

Yes, Glasionomer Cement CX Plus is supplied as a single-use product. This ensures product integrity and prevents cross-contamination between patients, which is essential for maintaining sterility and safety in dental procedures.

What are the storage requirements for Glasionomer Cement CX Plus?

Glasionomer Cement CX Plus requires proper storage conditions to maintain its integrity. While specific storage details aren't provided in the device data, it's generally recommended to store dental cements in a cool, dry place as per manufacturer instructions to preserve their chemical properties and effectiveness.

What is the regulatory classification of Glasionomer Cement CX Plus?

Glasionomer Cement CX Plus is classified as a Class II medical device by the FDA and has received 510(k) clearance for dental applications. This means it has been determined to be substantially equivalent to other legally marketed devices of the same type.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shofu Dental Corp.

Sources (1)

  • FDA 510(k) K982461 24 fields · synced Sep 23, 2026