Ionofil Plus AC
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identity
- Trade Name
- Ionofil Plus EUDAMED
- Device Name
- Ionofil Plus EUDAMED
- Model / Reference
- 1525 EUDAMED1522 EUDAMED1524 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E22115251 EUDAMEDE22115221 EUDAMEDE22115241 EUDAMED
- Basic UDI-DI
- ++E221020300000000072 EUDAMED
- 510(k) Number
- K042669 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Ionofil Plus AC is a glass ionomer restorative material, classified as a dental cement. It is designed for dental applications requiring durable, fluoride-releasing restorations with a spreadable consistency, ensuring good marginal adaptation and wetting behavior for optimal placement and longevity in restorative procedures.
This material is supplied as a set of capsules in three shades (A1, A3, B3) and includes 3 ml of VOCO Final Varnish LC. It is intended for single-use in clinical settings and is regulated under the FDA 510(k) pathway with a Special Clearance (K042669) and the EU Medical Device Regulation (MDR). The product adheres to dental standards for biocompatibility and aesthetic translucency, with no indication of MRI compatibility or reusability.
Frequently asked questions
What clinical scenarios is Ionofil Plus AC specifically designed for in dental restorations?
Ionofil Plus AC is designed for durable, fluoride-releasing dental restorations where a spreadable consistency is beneficial. Its formulation ensures good marginal adaptation and wetting behavior, making it ideal for procedures requiring precise placement and longevity, such as class II cavities, occlusal restorations, or areas needing aesthetic translucency.
How is Ionofil Plus AC supplied, and what additional components come with the kit?
Ionofil Plus AC is supplied as a set of capsules in three tooth shade options (A1, A3, B3) to match natural dentition. Each kit includes 3 ml of VOCO Final Varnish LC, which is intended for post-restoration sealing or protection. The material is packaged for single-use in clinical settings.
Is Ionofil Plus AC intended for reuse, or is it strictly single-use?
Ionofil Plus AC is explicitly designed for single-use in clinical settings. The product packaging and regulatory classification (as a dental cement) do not support reuse, and the manufacturer’s instructions align with this restriction to ensure sterility and performance.
What regulatory pathways does Ionofil Plus AC follow in the U.S. and EU?
In the U.S., Ionofil Plus AC is regulated under the FDA 510(k) pathway with a Special Clearance (K042669), classified as substantially equivalent to predicate devices. In the EU, it complies with the Medical Device Regulation (MDR), reflecting its classification as a Class II dental cement.
How should Ionofil Plus AC be stored to maintain its integrity?
While specific storage instructions aren’t detailed in the provided data, typical glass ionomer cements like Ionofil Plus AC should be stored in a cool, dry place away from direct sunlight and extreme temperatures. The single-use capsules should remain unopened until clinical use to preserve sterility and material properties.
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: Ionofil Plus - Glass Ionomer Materials | VOCO GmbH, VOCO Ionofil Molar AC · Quick - Glass Ionomer Materials | VOCO GmbH, Ionofil Plus AC - Dental Advisor
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K042669 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (4)
- FDA 510(k) K042669 24 fields · synced Oct 6, 2026
- EUDAMED bd8e3d05-8c82-48b3-b78b-7a5a11c3773c 61 fields · synced Jul 9, 2026
- EUDAMED 6fae6e2a-8299-49a9-8aaa-938799c4c9e5 61 fields · synced Jul 15, 2026
- EUDAMED 26deeedc-fd26-4360-9538-09b39e27987d 61 fields · synced Aug 4, 2026