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Fiber Disks and Blocks (TRINIA)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K143524

by Bicon, Llc

Identifiers

510(k) Number
K143524 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 Fiber Disks and Blocks (TRINIA) are dental implants designed for use in oral and maxillofacial procedures. These devices are intended to provide structural support and integration within bone tissue, facilitating long-term stability for dental restorations.

Supplied as single-use items, these fiber-based components are intended for use in controlled clinical environments such as dental offices and oral surgery clinics. Authorized under FDA 510(k) clearance (K143524) and compliant with MDD and MDR directives, they are classified under product code EBF for dental implants. Sterility and proper handling are critical for clinical application.

Frequently asked questions

Are the Fiber Disks and Blocks (TRINIA) meant for reuse in multiple patients, or are they single-use only?

The Fiber Disks and Blocks (TRINIA) are explicitly supplied as single-use items. This design ensures sterility and safety for each patient, reducing the risk of cross-contamination in clinical settings like dental offices or oral surgery clinics.

What types of clinical environments are these devices intended for, and why?

These devices are designed for controlled clinical environments such as dental offices and oral surgery clinics. Their fiber-based composition and single-use nature require sterile handling, making them suitable for procedures where precision and infection control are critical.

How are the Fiber Disks and Blocks (TRINIA) regulated, and what does that mean for their use?

The Fiber Disks and Blocks (TRINIA) are authorized under FDA 510(k) clearance (K143524) and comply with MDD and MDR directives. This means they meet regulatory standards for dental implants (product code EBF) and have been deemed substantially equivalent to a predicate device, ensuring their safety and effectiveness for structural support in oral and maxillofacial procedures.

What role do these fiber-based components play in dental procedures, and how do they integrate with bone tissue?

The Fiber Disks and Blocks (TRINIA) provide structural support within bone tissue during oral and maxillofacial procedures, helping to ensure long-term stability for dental restorations. Their fiber-based design is intended to integrate with the surrounding bone, facilitating secure placement for implants.

Are there specific storage requirements for the Fiber Disks and Blocks (TRINIA) to maintain their integrity?

While the provided data does not specify exact storage conditions, the emphasis on sterility and proper handling for single-use items implies they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Adherence to manufacturer guidelines for sterile packaging is critical to preserve their clinical suitability.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bicon, Llc

Sources (2)

  • FDA 510(k) K143524 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026