Identifiers
- 510(k) Number
- K250317 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)
EsFlow PLUS Injectable is a light-cured flowable composite resin designed for direct dental restorations. It incorporates uniform nano fillers to provide enhanced physical strength, making it suitable for use on occlusal surfaces while maintaining low extrusion force and thixotropic behavior. The material also offers excellent gloss retention and eliminates stringing, ensuring smooth application.
This device is supplied as a single-use, injectable composite resin and is intended for use in dental settings. It is not sterile at the point of sale but is packaged to prevent contamination. The product is available in a range of shades to accommodate various restorative needs. Regulatory clearance for EsFlow PLUS Injectable has been granted under the FDA 510(k) pathway, with a decision code of SESE (Substantially Equivalent)
Frequently asked questions
Is EsFlow PLUS Injectable meant for use on specific types of dental surfaces, and why is it recommended for those areas?
EsFlow PLUS Injectable is specifically designed for direct dental restorations, particularly on occlusal surfaces (the biting surfaces of teeth). Its formulation includes uniform nano fillers to provide enhanced physical strength, which makes it well-suited for areas requiring durability and resistance to wear. Additionally, its low extrusion force and thixotropic behavior ensure smooth application and minimize complications during placement.
How is EsFlow PLUS Injectable supplied, and what precautions should be taken before use?
EsFlow PLUS Injectable is supplied as a single-use, injectable composite resin. It is not sterile at the point of sale but is packaged to prevent contamination, so clinicians should handle it with care to maintain sterility before use. The product comes in a range of shades to match different restorative needs, ensuring versatility in dental applications.
Can EsFlow PLUS Injectable be reused, and if not, why is it designed for single-use?
No, EsFlow PLUS Injectable is explicitly designed for single-use only. This is likely due to its light-cured, injectable nature, which may compromise its structural integrity or sterility if reused. Single-use also reduces the risk of cross-contamination and ensures consistent performance for each patient.
What regulatory pathway was followed for EsFlow PLUS Injectable, and what does that mean for its use in dental practices?
EsFlow PLUS Injectable received FDA clearance through the 510(k) pathway, specifically under the 'Substantially Equivalent' (SESE) decision code. This means the device was determined to have the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device. Clinicians can rely on this clearance as evidence of its compliance with FDA standards for dental composites.
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: 스피덴트 Spident, PDF Spident CO., LTD - dentaladvisor.com, 스피덴트 Spident, EsFlow PLUS by Spident CO. LTD | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250317 | Class II | Active |
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Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (1)
- FDA 510(k) K250317 24 fields · synced Sep 19, 2026