Filtek One Bulk Fill Restorative
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K163207 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)
Filtek One Bulk Fill Restorative is a dental device classified under the product code EBF and reviewed by the Dental advisory committee (DE). It is a resin composite restorative material designed for posterior restorations.
The device is supplied as a bulk fill composite material intended for one-step placement up to 5mm in depth. It is manufactured by 3M Company and received FDA 510(k) clearance (K163207) on November 28, 2016, as substantially equivalent to a predicate device.
Frequently asked questions
What types of dental restorations is this composite material designed for, and how does its bulk-fill feature work?
Filtek One Bulk Fill Restorative is specifically designed for posterior restorations, which are fillings in the back teeth. The bulk-fill feature allows clinicians to place the material in a single step up to a depth of 5 millimeters, reducing the need for incremental layering and streamlining the restoration process.
Is this product intended for single-use or can it be reused after initial application?
Filtek One Bulk Fill Restorative is formulated as a restorative material for one-time placement in a patient’s mouth. Like most dental composites, it is not designed for reuse after initial curing and application, as it bonds directly to tooth structure during the restoration process.
How is this product supplied, and does it come in multiple sizes or models?
Filtek One Bulk Fill Restorative is supplied as a bulk-fill composite material, meaning it is packaged for direct placement in larger cavities without requiring layering. While the exact shade or shade options are not specified in the data, the product is likely available in various shades to match natural tooth color, though no specific sizes or models beyond the bulk-fill depth (up to 5mm) are detailed.
What is the sterility status of this product, and how should it be stored?
The data does not explicitly state whether Filtek One Bulk Fill Restorative is sterile or non-sterile. However, as a dental restorative material intended for direct contact with oral tissues, it is typically supplied in a non-sterile form for clinical use. Proper storage should follow the manufacturer’s guidelines, which likely include keeping it in a cool, dry place away from direct sunlight to maintain material integrity until use.
What was the regulatory pathway used for FDA clearance, and which advisory committee reviewed this submission?
Filtek One Bulk Fill Restorative received FDA clearance through a traditional 510(k) pathway, which demonstrates that the device was determined to be substantially equivalent to a predicate device already on the market. The submission was reviewed by the Dental (DE) Advisory Committee, which specializes in dental products, ensuring the device met regulatory standards for posterior restorative materials.
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: 3M™ Filtek™ One Bulk Fill Restorative, 3M™ Filtek™ One Bulk Fill Restorative, 3M™ Filtek™ One Bulk Fill Restorative - Dental Advisor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163207 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K163207 24 fields · synced Sep 19, 2026