Pulpdent Solo Flowable Composite with MCP
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153249 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 Pulpdent Solo Flowable Composite with MCP is a flowable dental restorative material classified under Material, Tooth Shade, Resin. It is designed to release fluoride, calcium, and phosphate ions, providing restorative, base, and liner applications in dental procedures. This composite is formulated to offer enhanced mechanical properties and ease of placement for dental professionals.
This device is supplied as a single-use, non-sterile material intended for use in dental offices. It is regulated under FDA 510(k) clearance (K153249) with a product code of EBF, and its use adheres to dental restorative standards. Storage and handling should follow manufacturer guidelines to ensure optimal performance and safety.
Frequently asked questions
What types of dental procedures is this composite material intended for, and how does it differ from traditional composites?
The Pulpdent Solo Flowable Composite with MCP is designed for restorative, base, and liner applications in dental procedures. Unlike traditional composites, it is formulated to release fluoride, calcium, and phosphate ions, which helps strengthen tooth structure and improve mechanical properties. Its flowable consistency also makes it easier to place compared to standard composites, reducing technique sensitivity for dental professionals.
Is this material single-use or reusable, and how should it be stored to maintain its integrity?
This composite is supplied as a single-use material, meaning each application requires a new unit. To ensure optimal performance and safety, storage should follow the manufacturer’s guidelines, which likely include keeping it in a cool, dry place away from direct sunlight and extreme temperatures. Proper storage helps preserve its mechanical properties and ion-releasing capabilities.
What regulatory pathway does this device follow, and what does the FDA’s clearance mean for its use?
The Pulpdent Solo Flowable Composite with MCP follows the FDA’s 510(k) clearance process, specifically under product code EBF (Dental Restorative Materials). The clearance (K153249) indicates the device is deemed *substantially equivalent* to a legally marketed predicate, meaning it meets the same performance standards for dental restorative applications. This does not imply approval for specific clinical outcomes but confirms compliance with FDA requirements for safety and effectiveness as a flowable composite.
How does the MCP formulation benefit dental restorations compared to standard flowable composites?
The MCP (likely referring to mineralized collagen particles or a similar bioactive component) in this composite releases fluoride, calcium, and phosphate ions, which actively remineralize tooth structure and promote long-term durability. This distinguishes it from standard flowable composites, which typically lack these bioactive properties, making it suitable for applications where enhanced remineralization and mechanical strength are desired.
Since it’s non-sterile, what precautions should a dental office take when handling or preparing this material?
Because the material is non-sterile, dental offices should follow standard infection control protocols when handling it, such as using sterile instruments for application and adhering to aseptic techniques during placement. The manufacturer’s guidelines likely include specific recommendations for preparation (e.g., mixing, application tools) to minimize contamination risks while maintaining the material’s intended performance.
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: Pulpdent Solo Flowable Composite with MCP (K153249) — FDA 510(k ..., FDA 510 (k) K153249, Pulpdent Solo Flowable Composite with MCP, by ..., Pulpdent Solo Flowable Composite With MCP 510(k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153249 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K153249 24 fields · synced Sep 18, 2026