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Ufi Gel Hard C

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K143486

by VOCO GmbH

Identifiers

510(k) Number
K143486 FDA 510(k)
FDA Product Code
EBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3760 FDA 510(k)
Regulation Number
872.3760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ufi Gel Hard C is a hard direct denture relining material (Product Code: EBI) designed for chairside rebasing of dentures. It is a methyl methacrylate-free composite-based system that provides a durable, rigid restoration with high patient acceptance and biocompatibility.

This material is supplied in a 1:1 cartridge system for automated, bubble-free mixing, enabling complete relining in 10–15 minutes. It is intended for single-use, non-sterile application in dental settings and achieves neutral taste, minimal exothermic temperature (98.6 °F), and excellent colour stability. Authorised under FDA 510(k) clearance (K143486) and MDR compliance, it requires proper handling and disposal as per dental protocols.

Frequently asked questions

What types of dentures is Ufi Gel hard C specifically designed to reline, and how does its methyl methacrylate-free formula benefit patients?

Ufi Gel hard C is designed for chairside rebasing of dentures, providing a durable and rigid restoration. Its methyl methacrylate-free composite-based formula improves biocompatibility and reduces patient sensitivity, which is particularly beneficial for those with allergies or sensitivities to traditional acrylic materials. The material also ensures a neutral taste and minimal exothermic reaction (98.6°F), enhancing patient comfort during and after the procedure.

How is Ufi Gel hard C supplied, and what makes its 1:1 cartridge system advantageous for dental professionals?

Ufi Gel hard C is supplied as a 1:1 cartridge system, which automates the mixing process and eliminates bubbles, ensuring a smooth and efficient relining procedure. This system allows for complete relining in just 10–15 minutes, streamlining workflow in the dental chair and reducing the risk of voids or imperfections in the final restoration.

Is Ufi Gel hard C intended for reuse, and what storage or handling considerations should be taken into account?

Ufi Gel hard C is explicitly designed for single-use only, meaning each cartridge should be used once and then discarded. Since it is non-sterile, it must be handled in a controlled dental setting following standard infection control protocols. Storage should adhere to manufacturer guidelines to maintain material integrity, though specific conditions (e.g., temperature or humidity) are not detailed in the provided data.

What regulatory pathways does Ufi Gel hard C follow, and how does this affect its use in clinical practice?

Ufi Gel hard C is authorized under FDA 510(k) clearance (K143486) and MDR compliance, confirming its equivalence to existing dental relining materials and adherence to European and U.S. regulatory standards. Clinicians can rely on its authorized status for chairside rebasing, ensuring it meets established safety and performance criteria. The clearance also reflects its classification under Product Code EBI (Dental), confirming its intended use for denture relining.

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: Ufi Gel hard C · Ufi Gel hard - Denture Relining | VOCO GmbH, Ufi Gel hard C - Direct Denture Relining | VOCO GmbH, UFI Gel Hard C: Hard relining material - VOCO - Dentaltix

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
VOCO GmbH

Sources (2)

  • FDA 510(k) K143486 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026