Identifiers
- 510(k) Number
- K071452 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FL-Bond II is a self-etching, fluoride-releasing adhesive system for dental use, classified as an agent for tooth bonding. It consists of a two-step process—primer and bonding agent—to create a durable bond between restorative materials and both enamel and dentin, ensuring a secure marginal seal for anterior and posterior restorations. Its radiopacity and self-etching properties enhance clinical versatility and bonding reliability.
This adhesive system is supplied as a dual-component kit, intended for single-use per application. It is designed for use in dental offices under aseptic conditions, with no specific regulatory mention of MRI safety or sterilisation requirements beyond standard dental practice protocols. The system is available in standard dental packaging, and its regulatory status includes FDA 510(k) clearance under the classification of dental adhesives. No additional storage conditions beyond manufacturer guidelines are specified.
Frequently asked questions
What is the FL-Bond II adhesive system used for?
The FL-Bond II is a self-etching, fluoride-releasing adhesive designed specifically for dental bonding. It creates a strong, durable bond between restorative materials and both enamel and dentin, ensuring a secure marginal seal for both anterior (front) and posterior (back) dental restorations. Its self-etching properties simplify preparation, while fluoride release helps remineralize tooth surfaces.
How is the FL-Bond II adhesive system supplied, and is it single-use?
The FL-Bond II is supplied as a dual-component kit, containing a primer and bonding agent. It is intended for single-use per application, meaning each kit should be discarded after one use to maintain sterility and clinical safety. This aligns with standard dental practice protocols for adhesive systems.
Does the FL-Bond II require any special storage conditions?
The FL-Bond II does not specify any additional storage conditions beyond the manufacturer’s general guidelines. It should be stored under typical dental office conditions—protected from extreme temperatures, moisture, and direct sunlight—until use. Always follow the packaging instructions for optimal shelf life.
Is the FL-Bond II radiopaque, and why does this matter?
Yes, the FL-Bond II is radiopaque, meaning it appears visible on dental X-rays. This feature is clinically valuable because it allows dentists to confirm proper placement of the adhesive layer beneath restorations. Visibility on radiographs helps verify the bond’s integrity and ensures no gaps exist between the restoration and tooth structure.
Can the FL-Bond II adhesive system be reused, or is it designed for single applications?
The FL-Bond II is explicitly designed for single-use per application. Reusing components violates aseptic protocols and could compromise sterility, increasing the risk of contamination or infection. Each kit is intended to be opened once and discarded afterward, adhering to standard dental hygiene practices for adhesive systems.
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: FL-Bond II - Shofu, FL-Bond II - Shofu Dental, Shofu FL-BOND II Adhesives - Shofu Dental, FL-Bond II - SHOFU Dental
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071452 | Class II | Active |
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Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA 510(k) K071452 24 fields · synced Oct 1, 2026