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Zimmer Zfx Titanium Abutment, Base Abutment And Abutment Blank For Nobelactive …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K134045

by Zimmer Dental Inc.

Identifiers

510(k) Number
K134045 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 Zimmer Zfx Titanium Abutment, Base Abutment and Abutment Blank for NobelActive Implant System is a patient-specific dental implant abutment with a competitor-compatible interface. It is designed to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments.

This device is supplied as a pre-fabricated titanium abutment blank for in-lab production of one-piece customized titanium abutments. It received FDA 510(k) clearance (K134045) as a substantially equivalent device under product code NHA, reviewed by the Dental advisory committee.

Frequently asked questions

What is the Zimmer Zfx Titanium Abutment used for?

It is a patient-specific dental implant abutment blank designed for in-lab production of customized one-piece titanium abutments to meet clinical needs that off-the-shelf abutments cannot satisfy, specifically for the NobelActive implant system.

How is the Zimmer Zfx Titanium Abutment supplied and is it reusable?

It is supplied as a pre-fabricated titanium abutment blank intended for single-use in-lab manufacturing of customized abutments; it is not intended for reuse after milling or modification.

What regulatory pathway was used for the Zimmer Zfx Titanium Abutment?

The device received FDA 510(k) clearance (K134045) as a substantially equivalent device under product code NHA, reviewed by the Dental advisory committee, based on a traditional submission.

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: Effiziente Automatisierungstechnik - Zimmer Group, Zimmer Zfx Titanium Abutment, Base Abutment and Abutment Blank for ..., Zimmer Zfx Titanium Abutment, Base Abutment and Abutment Blank for ..., Zfx Dental: Excellence in dental Innovation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zimmer Dental Inc.
FDA Applicant
Zimmer Dental, Inc.

Sources (1)

  • FDA 510(k) K134045 24 fields · synced Oct 6, 2026