Identifiers
- 510(k) Number
- K971594 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)
Flow-Rite is a visible light-cured flowable composite dental restorative material, classified under product code EBF as a resin-based dental filling material. It is designed to restore tooth structure in cavities by filling voids and providing durable, aesthetic repair work in dental offices.
The device is supplied as a smooth paste and intended for single-use application by dental clinicians. It requires curing with a visible light source for 30–40 seconds to achieve its restorative properties. Authorized under FDA 510(k) clearance (K971594) as substantially equivalent, it adheres to dental industry standards for Class II devices under special controls.
Frequently asked questions
What types of dental cavities is Flow-Rite designed to repair and how does it differ from traditional fillings?
Flow-Rite is a visible light-cured flowable composite material specifically designed to restore tooth structure in cavities by filling voids and providing durable, aesthetic repairs. Unlike traditional fillings, it is formulated as a smooth paste that flows easily into tight spaces, making it ideal for small to moderate cavities where precision and a natural appearance are important. It requires curing with a visible light source for 30–40 seconds to harden and achieve its restorative properties.
Is Flow-Rite intended for reuse or is it meant to be used only once per application?
Flow-Rite is explicitly supplied as a single-use product. Each application requires a fresh dose of the material, as it is designed for one-time use by dental clinicians to ensure optimal performance and sterility during restorative procedures.
How is Flow-Rite packaged and stored to maintain its integrity before use?
While the exact packaging details aren’t specified, Flow-Rite is supplied as a smooth paste intended for single-use in dental offices. To preserve its sterility and effectiveness, it should be stored according to the manufacturer’s instructions (likely in a sealed, airtight container) away from direct light and extreme temperatures, as composites can degrade if exposed to heat or UV light before curing.
What is the curing process for Flow-Rite, and why is it important?
Flow-Rite requires curing with a visible light source for 30–40 seconds to fully harden and achieve its restorative properties. This step is critical because it activates the resin-based material, allowing it to bond securely to tooth structure and form a durable, aesthetically pleasing repair. Skipping or insufficient curing can lead to softness, poor adhesion, or premature failure of the restoration.
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: FLOW-RITE (K971594) — FDA 510(k) | Innolitics, K971594 FDA 510(k) - FLOW-RITE | Pulpdent Corp., Flows-Rite (Pulpdent) - skydentalsupply.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971594 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K971594 24 fields · synced Sep 18, 2026