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Zimmer 3.1mm Dental Implant +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142082

by Zimmer Dental Inc.

Identifiers

510(k) Number
K142082 FDA 510(k)
FDA Product Code
DZE FDA 510(k)
Models / Variants
Zimmer 3.1mm Dental Implant FDA 510(k)
2.9mm Angled Abutment FDA 510(k)
straight Hex, 2.9mm Contour Abutement FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Zimmer 3.1 mm Dental Implant; 2.9 mm Angled Abutment; Straight Hex, 2.9 mm Contour Abutment is a dental implant system designed for use in oral and maxillofacial surgery. This system includes a 3.1 mm implant body and two abutments: a 2.9 mm angled abutment and a 2.9 mm straight hex contour abutment. These components are intended to support cemented dental prostheses, particularly where an angular offset of 17° is required. The conical connection of the implant ensures secure stress distribution, enhancing long-term stability.

This device is supplied as a sterile, single-use system for surgical use in oral and maxillofacial procedures. The 3.1 mm implant body pairs with the 2.9 mm abutments, which are designed for intermediate or terminal prosthetic applications. The system has received FDA 510(k) clearance (K142082) under the Traditional pathway and is classified as a Class II medical device. Proper storage and handling must comply with standard sterile surgical instrument protocols.

Zimmer 3.1 mm Dental Implant; 2.9 mm Angled Abutment; Straight Hex, 2.9 mm Contour Abutment

Frequently asked questions

What specific clinical scenarios is this dental implant system designed to address, and why is the 17° angled abutment included?

This system is designed for oral and maxillofacial surgery to support cemented dental prostheses where an angular offset of 17° is required. The angled abutment allows for better alignment of the prosthetic crown with the natural tooth arch, particularly in cases where the implant’s natural axis doesn’t match the desired prosthetic axis. This helps restore proper occlusion and aesthetics, reducing the need for complex prosthetic adjustments.

Is this system intended for reuse, or is it meant to be used only once per patient? How should it be stored to maintain sterility?

This system is explicitly labeled as sterile and single-use, meaning each component is intended for one surgical procedure per patient. To maintain sterility, it should be stored in its original packaging, sealed and unopened, in a clean, dry environment away from direct sunlight or extreme temperatures. Follow standard sterile surgical instrument protocols to prevent contamination before use.

What are the key differences between the angled and straight hex contour abutments, and how do they influence prosthetic design?

The 2.9 mm angled abutment is designed with a 17° offset to correct misalignment between the implant’s natural axis and the desired prosthetic axis, which is critical for restoring proper bite function and aesthetics. The straight hex contour abutment provides a standard connection for prosthetics where no angular correction is needed. Both abutments pair with the 3.1 mm implant body but offer flexibility in prosthetic design—angled for cases requiring tilt correction, straight for conventional alignment.

How do I confirm the regulatory clearance status of this device, and what does the FDA 510(k) clearance (K142082) imply for its use?

The device holds FDA 510(k) clearance (K142082) under the Traditional pathway, meaning it has been determined *substantially equivalent* to a legally marketed predicate device. This clearance confirms it meets U.S. safety and effectiveness requirements for its intended use in supporting cemented dental prostheses. For full details, you can verify the clearance status via the FDA’s [Premarket Notification (510(k)) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm) using the K-number (K142082).

Are there multiple sizes or models available in this system, and how do the 3.1 mm implant and 2.9 mm abutments pair together?

This system consists of a single implant size (3.1 mm diameter) paired with two abutment types (both 2.9 mm diameter)—one angled at 17° and one straight hex contour. The abutments are interchangeable with the implant body, allowing clinicians to select the appropriate angle for prosthetic alignment. The conical connection ensures a secure, stress-distributing fit, enhancing long-term stability regardless of the abutment choice.

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 3.1mm Dental Implant;2.9mm Angled Abutment;Straight Hex, 2.9mm ..., Zimmer 3.1mm Dental Implant;2.9mm Angled Abutment;straight Hex, 2.9mm ..., Zimmer 3.1mm Dental Implant;2.9mm Angled Abutment;Straight Hex, 2.9mm ..., 3.1 mmD Implant System - Zimmer Dental - MedicalExpo

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) K142082 24 fields · synced Oct 6, 2026