Identifiers
- 510(k) Number
- K974483 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 NTL-FLOW is a dental material classified as a Material, Tooth Shade, Resin under FDA product code EBF. It is a low-viscosity, light-cure hybrid composite designed for dental restorative applications, providing shade-matching capabilities for tooth-colored fillings.
Supplied as a single-use dental material, NTL-FLOW is intended for use in clinical settings by dental professionals. It requires no special storage conditions and is regulated under the FDA’s Traditional 510(k) pathway, with clearance granted in 1998. The device is classified as Class II and is not intended for MRI use. No additional regulatory markings or sterility claims are specified.
Frequently asked questions
What is the NTL-FLOW composite used for in dental restorations?
The NTL-FLOW is a low-viscosity, light-cure hybrid composite designed specifically for dental restorative applications. Its primary purpose is to provide shade-matching capabilities for tooth-colored fillings, ensuring natural-looking results when restoring teeth. The material’s low viscosity allows for easy placement and adaptation to the tooth structure, making it ideal for filling cavities or repairing minor dental defects.
How is the NTL-FLOW composite supplied, and is it single-use?
The NTL-FLOW composite is supplied as a single-use dental material. This design ensures sterility and consistency for each clinical application, reducing the risk of cross-contamination between patients. Single-use materials are also convenient for dental professionals, as they eliminate the need for cleaning, sterilization, or reprocessing between uses.
Does the NTL-FLOW composite require special storage conditions?
No, the NTL-FLOW composite does not require any special storage conditions. It can be stored under standard clinical conditions, such as room temperature and dry environments, without compromising its performance or shelf life. Always follow the manufacturer’s guidelines for optimal handling and storage to maintain product integrity.
Is the NTL-FLOW composite suitable for MRI use?
No, the NTL-FLOW composite is explicitly not intended for MRI use. This is important for dental professionals to note, as MRI-compatible materials are designed to avoid interference with magnetic resonance imaging. If a patient may require an MRI in the future, ensure that any residual composite material is fully removed or that the patient is informed of potential risks.
What regulatory pathway was used for FDA clearance of the NTL-FLOW composite?
The NTL-FLOW composite was cleared through the FDA’s Traditional 510(k) pathway, which demonstrates that it is substantially equivalent to a legally marketed predicate device. This pathway was used in 1998, and the device was classified as Class II by the FDA. The clearance was granted under the Dental advisory committee (DE), with Bisco, Inc. as the applicant. This classification means it is subject to general controls and special controls to ensure safety and effectiveness.
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: NTL-FLOW (K974483) — FDA 510 (k) | Innolitics, K974483 FDA 510 (k) - NTL-FLOW | Bisco, Inc., NTL-FLOW 510 (k) K974483 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974483 | Class II | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K974483 24 fields · synced Oct 1, 2026