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Aqua Ionofil

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922853

by VOCO GmbH

Identifiers

510(k) Number
K922853 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)

Aqua Ionofil is a water-mixable glass ionomer restorative material used in dental procedures. It is supplied as a powder that is simply mixed with water to achieve a spreadable consistency, providing good marginal adaptation and aesthetic results. The formulation is designed to avoid overacidification during setting.

The device is a Class II dental cement under FDA product code EMA, cleared via 510(k) under number K922853. It is supplied by Voco GmbH and intended for single-use in restorative applications. Storage conditions and specific handling instructions are determined by the manufacturer, and the device is not evaluated for use in MRI environments.

Frequently asked questions

What is Aqua Ionofil used for?

Aqua Ionofil is a water-mixable glass ionomer restorative material used in dental procedures. It is designed to provide good marginal adaptation and aesthetic results while avoiding overacidification during setting.

How is Aqua Ionofil supplied?

Aqua Ionofil is supplied as a powder that is mixed with water to achieve a spreadable consistency. This formulation allows for easy handling and application in restorative dental procedures.

Is Aqua Ionofil single-use or reusable?

Aqua Ionofil is intended for single-use in restorative applications. This ensures sterility and consistency for each patient, reducing the risk of cross-contamination.

What are the storage conditions for Aqua Ionofil?

Storage conditions and specific handling instructions are determined by the manufacturer. It is important to follow these guidelines to maintain the material's integrity and performance.

What is the regulatory status of Aqua Ionofil?

Aqua Ionofil is a Class II dental cement under FDA product code EMA, cleared via 510(k) under number K922853. It is not evaluated for use in MRI environments.

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: Aqua Ionofil Plus - Glass Ionomer Materials | VOCO GmbH, Aqua Ionofil Plus - Glasionomer Materialien | VOCO GmbH, K922853 - AQUA IONOFIL | FDA 510(k) | Voco GmbH, AQUA IONOFIL (K922853) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
VOCO GmbH

Sources (1)

  • FDA 510(k) K922853 24 fields · synced Oct 6, 2026