Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow…
FDA 510(k)Class II (US FDA 510(k))
by Nobio Ltd
Identifiers
- 510(k) Number
- K201010 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 Infinix Universal Composite, Infinix Flowable Composite, and Infinix Bulk Fill Flow Composite are light-cured, resin-based restorative materials used in dental applications. They are part of the Infinix Family of Dental Composites and feature silica-based filler particles decorated with quaternary ammonium functional groups (QASi) covalently bound via silane linkers. These materials provide antibacterial protection and are engineered for speed and precision.
The Infinix composites are supplied in forms such as a 2g syringe and have a low viscosity, allowing for up to 4 mm cure depth. They are intended for use in dental restorations, providing active antibacterial protection at the pulpal floor and margins. The devices have received FDA 510K clearance, indicated by the K number K201010, and are classified under product code EBF.
Frequently asked questions
What are the Infinix Composites used for?
The Infinix Composites are used in dental restorations, providing active antibacterial protection at the pulpal floor and margins.
How are the Infinix Composites supplied?
The Infinix Composites are supplied in forms such as a 2g syringe with low viscosity, allowing for up to 4 mm cure depth.
Do the Infinix Composites have any special properties?
Yes, they feature silica-based filler particles decorated with quaternary ammonium functional groups (QASi) covalently bound via silane linkers, providing antibacterial protection.
What is the regulatory status of the Infinix Composites?
The devices have received FDA 510K clearance, indicated by the K number K201010, and are classified under product code EBF.
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: Infinix Flowable Composite | Infinix.com Global, Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk ..., Nobio receives FDA Clearances for Infinix™ Flowable and Bulk Fill ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201010 | Class II | Active |
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Manufacturer
- Manufacturer
- Nobio Ltd
- FDA Applicant
- Nobio , Ltd.
Sources (1)
- FDA 510(k) K201010 24 fields · synced Sep 27, 2026