Identifiers
- 510(k) Number
- K940122 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)
This dental luting cement is classified as a glass ionomer cement, designed for permanent cementation of restorations. It combines glass and polymer components to provide a biocompatible adhesive that bonds to tooth structure and restorative materials, ensuring durable fixation in dental applications.
Supplied as a two-part system, the cement is intended for use in clinical settings by dental professionals. It is packaged in sterile form for single-use, with specific lot numbers and registration details available for traceability. The device has received FDA 510(k) clearance under the classification of Dental Cement (Device Class II) and adheres to regulatory requirements for dental materials, including registration number 872.3275.
Frequently asked questions
What is the primary purpose of the HY BOND, GLASIONOMER CX dental luting cement, and how does it differ from other dental cements?
The HY BOND, GLASIONOMER CX is a glass ionomer cement specifically designed for the permanent cementation of dental restorations. Unlike some other cements, it combines glass and polymer components to create a biocompatible adhesive that bonds directly to both tooth structure and restorative materials, ensuring strong and durable fixation. This dual-bonding capability helps reduce the risk of loosening over time, making it suitable for long-term dental applications.
Is the HY BOND, GLASIONOMER CX single-use or reusable, and how is it packaged for clinical use?
The HY BOND, GLASIONOMER CX is supplied in a sterile, single-use format for clinical settings. Each package is designed for one-time use by dental professionals, ensuring sterility and traceability through included lot numbers and registration details. This prevents cross-contamination and maintains regulatory compliance for dental materials.
What regulatory pathway was followed for FDA clearance of this dental luting cement, and what classification does it fall under?
The HY BOND, GLASIONOMER CX received FDA 510(k) clearance under the classification of Dental Cement (Device Class II). The clearance was granted through a traditional 510(k) review, with the device deemed *substantially equivalent* to a predicate product. The submission was filed under the Dental (DE) Advisory Committee and assigned the registration number 872.3275, reflecting its compliance with dental material regulations.
How can I verify the authenticity or traceability of a HY BOND, GLASIONOMER CX package before use?
Each package of HY BOND, GLASIONOMER CX includes lot numbers and registration details, allowing for traceability. To verify authenticity, cross-reference these details with the manufacturer’s official records or contact Shofu Dental Corp. directly. This ensures the product meets regulatory standards and hasn’t been compromised during storage or transport.
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: HY-Bond GlasIonomer CX-Smart - Shofu, Shofu Hy-Bond Glasionomer CX Cement - Shofu Dental, Shofu Hy-Bond Glasionomer CX - Dental World Official, Shofu Hy-Bond Glasionomer Cx - zenodent.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940122 | Class II | Active |
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Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA 510(k) K940122 24 fields · synced Sep 19, 2026