Identifiers
- 510(k) Number
- K922251 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)
Ti-Core-Natural is a titanium-reinforced core build-up composite material used in dental applications. It is designed to match the strength of dentin and resists ditching and grooving during preparation common to other core build-up materials.
The device is supplied as a kit and is available in various sizes including Natural (A3). It is intended for single-use and is not MRI safe. The device has received FDA 510(k) clearance with product code EBF and is manufactured by Essential Dental Systems, Inc.
Frequently asked questions
What is Ti-Core-Natural used for in dental applications?
Ti-Core-Natural is a titanium-reinforced core build-up composite material designed to match the strength of dentin and resist ditching and grooving during preparation, which are common issues with other core build-up materials.
How is Ti-Core-Natural supplied and what sizes are available?
The device is supplied as a kit and is available in various sizes, including Natural (A3). This allows clinicians to select the appropriate size for their specific dental restoration needs.
Is Ti-Core-N sterile and can it be reused?
Ti-Core-Natural is intended for single-use only, meaning it should not be reused on multiple patients. The device is supplied in a sterile condition to ensure infection control protocols are maintained.
What is the regulatory status of Ti-Core-Natural?
Ti-Core-Natural has received FDA 510(k) clearance with product code EBF, indicating it has been determined to be substantially equivalent to predicate devices for its intended use in dental applications.
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 and Ti-Core Natural Core Build-Up Material from Essential ..., Ti-Core Build-Up, Kit, Natural (A3), 810-00 | Essential Dental Systems, Essential Dental Systems 810-00 TI-CORE KIT NATURAL, Dental Instruments ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922251 | Class II | Active |
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Manufacturer
- Manufacturer
- Essential Dental Systems, Inc.
Sources (1)
- FDA 510(k) K922251 24 fields · synced Sep 22, 2026