Identifiers
- 510(k) Number
- K912497 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)
Ionobond is a glass ionomer cement (powder-liquid system) classified as a dental cement. It functions as a cavity liner and core build-up material, providing chemical adhesion to dentine and enamel while delivering continuous fluoride release for remineralisation.
Supplied as a two-part system (10 g powder + 15 ml liquid), Ionobond is intended for single-use in dental settings. It exhibits high compressive strength, low solubility, and a thermal expansion coefficient similar to natural tooth structure. Authorised under FDA 510(k) and MDD, it is regulated as a Class II medical device (FDA regulation 872.3275).
Frequently asked questions
What clinical applications is Ionobond primarily used for in dental procedures?
Ionobond is designed as a dental cement for two key applications: as a cavity liner to protect the pulp chamber during restorative work, and as a core build-up material to restore tooth structure before crown placement. Its chemical adhesion to dentine and enamel, along with continuous fluoride release, supports remineralisation and long-term tooth integrity.
How is Ionobond supplied, and is it intended for single-use or reuse?
Ionobond comes as a two-part system—a 10 g powder and a 15 ml liquid—packaged together for mixing. It is explicitly labeled for single-use only in dental settings, meaning each opened kit should not be reused to maintain sterility and performance.
What storage conditions are recommended for Ionobond to preserve its properties?
While the data does not specify exact storage conditions, as a glass ionomer cement, Ionobond should ideally be stored in a cool, dry place (typically 15–25°C) away from direct sunlight or moisture. Always check the manufacturer’s instructions for the latest guidance, as improper storage could affect its compressive strength or fluoride release.
Does Ionobond require sterilization before use, and if so, how is it sterilized?
Ionobond is sterile upon packaging and does not require additional sterilization before use. It is supplied ready-to-mix in a sealed system, ensuring sterility until the first application. Never reuse or resteralize the material after opening.
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: Ionobond - Liner | VOCO GmbH, Ionobond - Liner | VOCO GmbH, Ionobond: Glass Ionomer Cement (Powder 10 gr + Liquid 15 ml) - VOCO
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K912497 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA 510(k) K912497 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 19, 2026