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Ribbond Triaxial

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K013881

by Ribbond, Inc.

Identifiers

510(k) Number
K013881 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)

The Ribbond Triaxial is a dental implant abutment system designed for use in dental prosthetics. It provides a triaxial connection between dental implants and prosthetic crowns or bridges, ensuring stability and precise alignment in oral rehabilitation procedures.

This device is supplied sterile and intended for single-use in clinical settings. It is classified under the product code EBI (Dental Implant Abutments) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The triaxial design facilitates secure attachment while accommodating variations in implant positioning, and it complies with the Medical Device Directive (MDD)

Frequently asked questions

What types of dental procedures is the Ribbond Triaxial abutment system designed to support, and why is the triaxial design important in these cases?

The Ribbond Triaxial is designed for dental prosthetics, specifically to connect dental implants with crowns or bridges. The triaxial design ensures greater stability and precision in alignment, which is critical for procedures where implant positioning may vary slightly. This design helps accommodate those variations while maintaining a secure attachment, reducing the risk of loosening or misalignment over time.

Is the Ribbond Triaxial system intended for reuse in clinical settings, and if not, what does this mean for cost management in a dental practice?

No, the Ribbond Triaxial is explicitly intended for single-use in clinical settings. This means each abutment is used once per patient, which helps minimize infection risks but may require practices to budget for higher consumable costs compared to reusable alternatives. The sterile packaging ensures safety for each procedure.

How should the Ribbond Triaxial abutment system be stored, and what considerations should clinicians keep in mind to maintain its integrity?

The Ribbond Triaxial is supplied sterile, so it should be stored according to the manufacturer’s instructions to preserve sterility. Typically, this involves keeping the packaging unopened and sealed until use, away from extreme temperatures or moisture. Clinicians should check expiration dates and ensure the device remains in its original, undamaged packaging until implantation.

What regulatory pathways has the Ribbond Triaxial undergone, and how does this affect its use in dental practices?

The Ribbond Triaxial has received FDA 510(k) clearance under the product code EBI (Dental Implant Abutments), with a decision of *Substantially Equivalent* to a predicate device. It also complies with the Medical Device Directive (MDD). This means it meets U.S. and EU regulatory standards for safety and effectiveness, allowing dental practices to use it with confidence in approved markets. The clearance confirms it’s been evaluated for clinical performance and risk.

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

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ribbond, Inc.

Sources (2)

  • FDA 510(k) K013881 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026