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Ti-Core Flow

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101504

by Essential Dental Systems, Inc.

Identifiers

510(k) Number
K101504 FDA 510(k)
FDA Product Code
EMA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ti-Core Flow is a Dental Cement designed for core build-up and post cementation in restorative dentistry. This titanium-reinforced composite material is formulated to provide mechanical strength comparable to dentin, reducing issues such as ditching or grooving during preparation. It serves as a versatile alternative to traditional composite, glass, or resin ionomer materials for structural reinforcement in dental restorations.

The device is supplied as a single-use, non-sterile material intended for clinical use in dental offices. It is classified as Class II under FDA regulations and has received FDA 510K clearance as substantially equivalent to predicate devices. Ti-Core Flow is compatible with bonding agents and offers high strength and rigidity for core build-up applications. Storage conditions and regulatory compliance align with dental cement standards, ensuring safe and effective use in restorative procedures.

Frequently asked questions

What is Ti-Core Flow used for in dental restorations?

Ti-Core Flow is a titanium-reinforced composite dental cement designed specifically for core build-up and post cementation in restorative dentistry. Its formulation provides mechanical strength comparable to natural dentin, reducing common issues like ditching or grooving during preparation. This makes it a versatile alternative to traditional composites, glass ionomers, or resin ionomers for structural reinforcement in dental restorations.

How is Ti-Core Flow supplied, and is it sterile?

Ti-Core Flow is supplied as a single-use, non-sterile material. It is intended for clinical use in dental offices, meaning it requires sterilization or preparation by the clinician before application. The non-sterile packaging ensures ease of handling and compatibility with standard dental office workflows.

Is Ti-Core Flow compatible with bonding agents, and what are its key advantages?

Yes, Ti-Core Flow is designed to be compatible with bonding agents commonly used in dentistry. Its key advantages include high strength and rigidity for core build-up, reducing the risk of structural failure during restoration. The titanium reinforcement enhances durability, mimicking the mechanical properties of dentin to prevent issues like ditching or grooving during preparation.

What storage conditions should be followed for Ti-Core Flow?

Ti-Core Flow should be stored according to standard dental cement guidelines to maintain its integrity and performance. Since it is non-sterile, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for optimal shelf life and usability, ensuring it remains effective for clinical procedures.

How does Ti-Core Flow differ from traditional dental cements?

Ti-Core Flow differs from traditional dental cements like composites, glass ionomers, or resin ionomers by incorporating titanium reinforcement, which provides mechanical strength comparable to dentin. This reduces the likelihood of ditching or grooving during preparation, offering greater durability and structural integrity for core build-up and post cementation. Its formulation also ensures compatibility with bonding agents, expanding its versatility in restorative dentistry.

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: Ti-Core Titanium-Reinforced Core Build-Up Composite | Essential Dental ..., Ti-Core Flow+ Titanium-Reinforced Core Build-Up & Post Cement | EDS, Ti-Core Flow Plus, Ti-Core Flow+, 832-00 | Essential Dental Systems |

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K101504 24 fields · synced Oct 1, 2026