Identifiers
- 510(k) Number
- K040236 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)
The Pulpdent VLC Resin Cement is a fluoride-releasing, visible light-cure dental resin cement. Classified as a dental cement, it is designed to permanently bond ceramic restorations—such as crowns, inlays, onlays, bridges, veneers, and periodontal splints—to natural tooth structure. Its formulation excludes Bisphenol A and relies on visible light activation for curing.
This device is intended for use in clinical dental settings by dental professionals. Supplied as a single-use product, it requires proper handling and storage to maintain sterility. The cement is regulated under FDA 510(k) clearance (K040236) as a Class II device (product code EMA), adhering to the Traditional 510(k) review pathway. No additional regulatory markings or MRI safety classifications are specified.
Frequently asked questions
What types of dental restorations can the Pulpdent VLC Resin Cement permanently bond to natural tooth structure?
The Pulpdent VLC Resin Cement is specifically designed to permanently bond ceramic restorations such as crowns, inlays, onlays, bridges, veneers, and periodontal splints to natural tooth structure. It is formulated to provide a strong, durable bond for these common dental restorative applications.
Is the Pulpdent VLC Resin Cement single-use or reusable, and how does this affect its handling?
The Pulpdent VLC Resin Cement is supplied as a single-use product. This means each application requires a new package to ensure sterility and prevent cross-contamination, which is critical in clinical dental settings where infection control is paramount.
How is the Pulpdent VLC Resin Cement cured, and what does this mean for its application process?
The Pulpdent VLC Resin Cement is cured using visible light activation, meaning a dental curing light must be used to harden the cement after it is applied between the restoration and tooth structure. This ensures proper bonding and sets the material efficiently during the procedure.
What regulatory pathway was followed for the FDA clearance of the Pulpdent VLC Resin Cement, and what does this imply about its safety and effectiveness?
The Pulpdent VLC Resin Cement was cleared through the FDA’s Traditional 510(k) review pathway, classified as a Class II device under product code EMA. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, implying it meets established safety and performance standards for dental cements.
How should the Pulpdent VLC Resin Cement be stored to maintain its sterility and usability?
Since the Pulpdent VLC Resin Cement is single-use and requires sterility, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the product remains uncontaminated and ready for clinical use when needed.
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 VLC RESIN CEMENT (K040236) — FDA 510(k) | Innolitics, K040236 - PULPDENT VLC RESIN CEMENT | FDA 510 (k), Cements Archives - PULPDENT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040236 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K040236 24 fields · synced Sep 20, 2026