Scotchbond Light Cured Dental Adhesive W/Fluoride
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K861899 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 Scotchbond Light-Cured Dental Adhesive with Fluoride is a dental bonding agent classified as a resin-based adhesive (product code EBF). It is designed to bond dental restorations to tooth structure using light activation, ensuring durable adhesion while incorporating fluoride for enhanced remineralisation and caries prevention. This adhesive is intended for use in restorative dentistry to improve the longevity of fillings, inlays, or other tooth restorations by creating a strong bond between the restoration material and the natural tooth.
This adhesive is supplied as a single-use, non-sterile product and is intended for professional dental use only. It requires light curing to activate and bond effectively, typically within a clinical setting. The device is regulated under FDA 510(k) clearance (K861899) and falls under the Dental advisory committee classification. No additional sterility or MRI safety considerations are specified, and it is not intended for reusable applications. Storage conditions are not detailed in the specifications but are typically recommended to be in a cool, dry place away from direct sunlight.
Frequently asked questions
What is the Scotchbond Light-Cured Dental Adhesive with Fluoride used for?
This adhesive is designed for bonding dental restorations—such as fillings, inlays, or other tooth repairs—to natural tooth structure. Its light-curing mechanism creates a strong, durable bond, while fluoride content helps remineralize tooth enamel and reduce the risk of cavities, extending the lifespan of restorations in restorative dentistry.
Is the Scotchbond Light-Cured Adhesive with Fluoride sterile?
No, this product is supplied as a non-sterile single-use adhesive. It is intended exclusively for professional dental use in a clinical setting, where sterilization of tools and surfaces is already managed. The adhesive itself does not require sterilization before application.
How is the Scotchbond Light-Cured Adhesive with Fluoride activated?
Activation occurs through light curing, a process where a dental curing light is used to polymerize the adhesive, forming a strong bond between the restoration material and tooth structure. This step is critical for ensuring proper adhesion and is performed during the restorative procedure.
Can the Scotchbond Light-Cured Adhesive with Fluoride be reused?
No, this adhesive is single-use only. Each application requires a fresh unit to maintain sterility and performance. Reusing it could compromise adhesion strength, introduce contamination, or reduce the fluoride remineralization benefits, which are designed for one-time clinical use.
What storage conditions are recommended for Scotchbond Light-Cured Adhesive with Fluoride?
While specific storage instructions aren’t detailed in the specifications, dental adhesives like this are generally recommended to be kept in a cool, dry place away from direct sunlight. Exposure to heat or moisture could degrade the adhesive’s properties over time, affecting its bonding efficacy and fluoride release.
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: K861899 - Scotchbond Light Cured Dental Adhesive W/Fluoride, Scotchbond Light Cured Dental Adhesive W/Fluoride - Beudamed, Dental adhesives | Solventum
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K861899 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K861899 24 fields · synced Oct 1, 2026