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TIB Abutments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222469

by Southern Implants (pty) Ltd

Identifiers

510(k) Number
K222469 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TIB Abutments are dental prosthetic components designed for use with dental implants. These abutments serve as the interface between the implant fixture and the final crown or prosthesis, ensuring stable and precise restoration placement in the oral cavity.

These abutments are supplied as premanufactured components and are intended for single-use in dental procedures. They feature an anti-rotational flat to prevent unwanted crown rotation, facilitating accurate positioning. The device is authorised under an FDA 510(k) clearance (K222469) and is classified under product code NHA for dental use.

Frequently asked questions

What is the primary purpose of the TIB Abutments in dental implant procedures?

The TIB Abutments act as the critical connection point between the dental implant fixture and the final crown or prosthesis. Their design ensures stable and precise placement of the restoration in the oral cavity, while the built-in anti-rotational flat prevents unwanted crown movement during use.

Are the TIB Abutments intended for reuse in multiple procedures, or are they single-use?

The TIB Abutments are explicitly designed for single-use only in dental procedures. This is a standard practice for prosthetic components to maintain sterility and patient safety, as reuse could compromise integrity and hygiene.

How are the TIB Abutments supplied, and what distinguishes their design from standard abutments?

The TIB Abutments are supplied as premanufactured components, ready for immediate use in dental implant procedures. Their distinguishing feature is the anti-rotational flat, which prevents crown rotation and ensures accurate, stable positioning during restoration placement.

What regulatory pathway was followed for the FDA clearance of the TIB Abutments?

The TIB Abutments received FDA 510(k) clearance (K222469) under the Traditional 510(k) review pathway, with a decision classification of *Substantially Equivalent* (SESE). The product is categorized under product code NHA, which pertains to dental abutments and connectors.

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: TIB Abutments - Southern Implants, TIB Abutments | Southern Implants, TIB Abutment - SOUTHERN IMPLANTS (Pty) Ltd. - PDF Catalogs | Technical ..., TIB Abutments by Southern Implants (Pty) Ltd | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Southern Implants (pty) Ltd
FDA Applicant
Southern Implants (Pty), Ltd.

Sources (1)

  • FDA 510(k) K222469 24 fields · synced Sep 19, 2026