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Zimmer Angled Contour Zirconia Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083474

by Zimmer Dental Inc.

Identifiers

510(k) Number
K083474 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 Angled Contour Zirconia Abutment is a dental implant component used as a terminal or intermediate abutment for cemented prostheses. It features a pre-defined offset margin—lower on the buccal aspect and higher on the lingual aspect—to reduce the need for chairside preparation. The abutment cone is fixed at a 17-degree angle and is intended for use in anterior and pre-molar regions. Its contoured collar below the margin allows space for soft tissue around the implant.

This single-use device is supplied sterile and is not intended for reuse or reprocessing. It is manufactured by Zimmer Dental Inc. and authorized under FDA 510(k) clearance with K-number K083474, classified under product code NHA and reviewed by the Dental advisory committee. The device is stored in a dry environment and is intended for use in clinical settings by qualified dental professionals.

Frequently asked questions

What is the Zimmer Angled Contour Zirconia Abutment used for?

It is a dental implant component used as a terminal or intermediate abutment for cemented prostheses. It is designed for use in anterior and pre-molar regions, featuring a pre-defined offset margin to reduce chairside preparation.

How is the Zimmer Angled Contour Zirconia Abutment supplied?

The device is supplied sterile and is intended for single use. It is not designed for reuse or reprocessing and should be stored in a dry environment.

What is the angle of the abutment cone?

The abutment cone is fixed at a 17-degree angle, which is intended to facilitate proper prosthetic alignment in specific clinical situations.

What is the regulatory status of this device?

The device was authorized under FDA 510(k) clearance with K-number K083474, classified under product code NHA and reviewed by the Dental advisory committee.

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: ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT (K083474) — FDA 510 (k ..., Zimmer Contour Zirconia Abutment from Zimmer Biomet, PDF DEC23 200s dental Special 510(k): Device Modification 510(k) SUMMARY ...

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) K083474 24 fields · synced Oct 6, 2026