Identifiers
- 510(k) Number
- K182296 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 HyperFil-LV is a dental filling material designed for use in restorative procedures. Classified under product code EBF, it is intended for filling cavities and restoring tooth structure, providing durable and biocompatible dental restoration.
Supplied as a reusable system, the HyperFil-LV is intended for use in clinical dental settings. It is cleared under FDA 510(k) (K182296) and the Medical Device Directive (MDD) for dental applications, adhering to regulatory standards for Class 2 devices. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What types of dental procedures is the HyperFil-LV intended for, and how does it differ from traditional filling materials?
The HyperFil-LV is specifically designed for restorative dental procedures, particularly for filling cavities and restoring tooth structure. Unlike some traditional filling materials, it is marketed as a durable and biocompatible option, which suggests it aims to provide long-lasting results while minimizing adverse reactions in the patient’s mouth. It is classified under FDA product code EBF, indicating its primary use in dental restorations.
Is the HyperFil-LV system single-use or reusable, and how does this affect its clinical use?
The HyperFil-LV is supplied as a reusable system, meaning it is intended for use in clinical dental settings where the components can be cleaned, sterilized, and reused across multiple procedures. This design reduces waste and cost per use compared to single-use systems, though proper sterilization protocols must be followed to ensure patient safety and maintain device integrity.
Are there any specific storage requirements for the HyperFil-LV, and how should it be handled to preserve its performance?
The provided data does not explicitly detail storage requirements for the HyperFil-LV system. However, as a reusable dental device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent contamination or degradation. Follow manufacturer guidelines for cleaning and sterilization to ensure optimal performance and longevity of the system.
What regulatory pathways has the HyperFil-LV followed, and what does this mean for clinicians or buyers?
The HyperFil-LV has undergone FDA clearance via a 510(k) submission (K182296), classified as substantially equivalent to a predicate device, and complies with the Medical Device Directive (MDD) for dental applications. This means it has met regulatory standards for safety and effectiveness as a Class 2 dental device, providing assurance of its suitability for clinical use in restorative procedures. Buyers can rely on this clearance for market availability and compliance.
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: K182296 FDA 510 (k) - HyperFil-LV | Parkell, Inc.
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 | K182296 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (2)
- FDA 510(k) K182296 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026