Silux Plus Light Cured Restorative Material
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K872444 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)
Silux Plus Light Cured Restorative Material is a dental composite material used for anterior restorations. It provides superior esthetics that maintain luster over time and offers a high degree of polishability to match enamel.
The material is available in multiple shade/opacity combinations and is supplied as a Class II device regulated under product code EBF. It received FDA 510(k) clearance with number K872444 on September 11, 1987, and is manufactured by 3M Company.
Frequently asked questions
What is Silux Plus Light Cured Restorative Material used for?
Silux Plus is a dental composite material specifically designed for anterior restorations. It provides superior esthetics that maintain luster over time and offers a high degree of polishability to match natural enamel.
How is Silux Plus Light Cured Restorative Material supplied?
The material is supplied as a Class II device regulated under product code EBF. It is available in multiple shade/opacity combinations to meet various clinical needs and esthetic requirements.
What is the regulatory status of Silux Plus Light Cured Restorative Material?
Silux Plus received FDA 510(k) clearance with number K872444 on September 11, 1987. It is manufactured by 3M Company and is classified as substantially equivalent to predicate devices.
How should Silux Plus Light Cured Restorative Material be stored?
The device data does not specify storage requirements for Silux Plus Light Cured Restorative Material. For proper storage, clinicians should follow the manufacturer's instructions provided with the product.
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: Silux Plus Light Cured Restorative Material, Silux Plus Light Cured Restorative Material 510 (k)… - FDA.report, 3M Silux Plus™ Anterior Restorative Dental Composite, Silux Plus™ product list - 3M, PDF 3M Silux PlusTM Anterior Restorative Dental Composite
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K872444 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K872444 24 fields · synced Sep 27, 2026