Grandio Core Dual Cure
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identifiers
- 510(k) Number
- K112447 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Grandio Core Dual Cure is a dental composite resin filling material designed for posterior restorations. Classified under the product code EBF, it is formulated to provide durable, aesthetic restorations in occlusal, proximal, and cervical areas of the teeth, offering dual-cure polymerization for enhanced bonding and mechanical strength.
This material is supplied as a two-component system, requiring mixing before use, and is intended for single-use applications in dental settings. It is not sterile at the point of supply but is packaged to maintain sterility until opened. The device is authorized under FDA 510K clearance and MDR compliance, adhering to dental industry standards for safety and performance. No MRI safety information or reusable specifications are provided in the data.
Frequently asked questions
What types of dental restorations is the Grandio Core Dual Cure specifically designed for, and why is dual-cure technology important in these areas?
The Grandio Core Dual Cure is designed for posterior restorations, including occlusal (biting surface), proximal (between teeth), and cervical (near the gumline) areas. Dual-cure technology combines chemical and light activation, ensuring complete polymerization even in hard-to-reach or thick sections of the restoration. This enhances bonding strength and mechanical durability, which is critical for areas subjected to heavy chewing forces.
How is the Grandio Core Dual Cure supplied, and what precautions should be taken when handling it before use?
The Grandio Core Dual Cure is supplied as a two-component system that requires mixing before application, meaning it comes in separate parts that must be combined by the clinician. Since it is not sterile at the point of supply, it is packaged to maintain sterility until opened. Clinicians should ensure the packaging remains intact until use and follow manufacturer guidelines for mixing to avoid contamination or improper curing.
Is the Grandio Core Dual Cure intended for single-use only, and if so, why does this matter in a dental practice?
Yes, the Grandio Core Dual Cure is intended for single-use applications. This matters in a dental practice because single-use materials reduce the risk of cross-contamination between patients, which is essential for infection control. Reusing dental materials can introduce bacteria or pathogens, posing health risks, so adhering to single-use protocols aligns with best practices for patient safety.
What regulatory pathways has the Grandio Core Dual Cure undergone, and how does this affect its use in clinical settings?
The Grandio Core Dual Cure has undergone FDA 510K clearance and MDR (Medical Device Regulation) compliance, confirming its substantial equivalence to existing dental composites and adherence to European safety standards. This means it has been evaluated for performance, safety, and efficacy by regulatory bodies, giving clinicians confidence in its reliability for posterior restorations. Clinicians should refer to the manufacturer’s instructions for specific usage guidelines tied to these approvals.
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 (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 | K112447 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA 510(k) K112447 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026