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Abutment for Competitive Implant Straumann Bone Level Connection

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112730

by Biomet 3i

Identifiers

510(k) Number
K112730 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)

This abutment is a dental prosthetic component designed for use with Straumann Bone Level implants. It serves as the interface between the implant fixture and the final prosthetic crown or restoration, enabling secure attachment and proper alignment for single or multiple tooth replacements. The device incorporates an internal engagement mechanism to prevent rotational instability, ensuring long-term stability of the restoration.

The abutment is supplied as a reusable, non-sterile component intended for use in dental clinical settings. It is configured to interface specifically with Straumann Bone Level implants and supports both screw-retained and cement-retained prostheses. The device holds an FDA 510(k) clearance under the product code NHA, with a decision classification of Substantially Equivalent. No additional regulatory markings or sterility claims are specified.

Frequently asked questions

Is this abutment meant for single-tooth or multi-tooth restorations, and how does it ensure stability for both cases?

This abutment is designed for use with both single and multiple tooth replacements when paired with Straumann Bone Level implants. Its internal engagement mechanism prevents rotational instability, which is critical for maintaining long-term stability of the prosthetic crown or restoration, whether it’s a standalone tooth or part of a larger bridge.

How is this abutment supplied, and what does that mean for clinical workflows?

The abutment is supplied as a reusable, non-sterile component, meaning it is intended to be cleaned, sterilized, and reused in clinical settings. Clinicians will need to follow proper sterilization protocols between uses, which may impact workflow efficiency but ensures cost-effectiveness over time.

Can this abutment be used with both screw-retained and cement-retained prostheses, and does it require any specific Straumann implant type?

Yes, this abutment is configured to support both screw-retained and cement-retained prostheses. However, it is specifically designed to interface with Straumann Bone Level implants only, ensuring compatibility and proper alignment for secure attachment of the final restoration.

What does the FDA 510(k) clearance under product code NHA mean for clinicians or dental practices considering this abutment?

The FDA 510(k) clearance under product code NHA indicates that this abutment has been deemed substantially equivalent to a legally marketed predicate device by the FDA, meaning it meets the agency’s requirements for safety and effectiveness for its intended use. Clinicians can rely on this classification as evidence of regulatory review, though they should always follow manufacturer guidelines and local regulations for proper use.

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: PDF Straumann® Bone Level Prosthetic Procedures, Was genau ist ein Abutment? - implantatzentrum-emsland.de, Abutment for Competitive Implant Straumann Bone Level Connection, Abutment: Das Verbindungsstück zwischen Implantat und Krone

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet 3i

Sources (1)

  • FDA 510(k) K112730 24 fields · synced Sep 19, 2026