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EM Provisional

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191751

by Hiossen, Inc.

Identifiers

510(k) Number
K191751 FDA 510(k)
FDA Product Code
DZE 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 EM Provisional Implant is classified as a dental implant abutment under the FDA’s product code DZE. It serves as a transitional component in dental implantology, designed to support provisional restorations during the osseointegration phase of implant therapy. Its RBM (Randomly Blasted Microstructure) surface enhances early bone integration, while the one-body connection ensures stability and alignment with the implant fixture.

This device is supplied as a single-use, sterile component intended for use in dental offices or clinics. Available in various diameters and lengths as specified in the FDA submission, it requires surgical placement by a trained dental professional. The EM Provisional Implant is regulated under FDA 510(k) clearance (K191751) and adheres to dental implant standards for biocompatibility and structural integrity. No MRI safety information is provided in the available data.

Frequently asked questions

What is the primary purpose of the EM Provisional Implant in dental implant therapy?

The EM Provisional Implant acts as a transitional abutment during the osseointegration phase of dental implant therapy. It supports provisional restorations while the bone integrates with the implant fixture, ensuring stability and alignment. Its RBM (Randomly Blasted Microstructure) surface is specifically designed to enhance early bone integration, making it a critical component for maintaining the implant’s position before the final restoration is placed.

Is the EM Provisional Implant intended for reuse, or is it designed for single-use only?

The EM Provisional Implant is explicitly supplied as a single-use, sterile component. This design ensures patient safety and hygiene, as it is intended to be used once and discarded after placement in a dental office or clinic. Reuse is not recommended or supported by the manufacturer.

What sizes or dimensions are available for the EM Provisional Implant, and how are they specified?

The EM Provisional Implant is available in various diameters and lengths, though the exact specifications are detailed in the FDA submission (K191751). These dimensions are tailored to accommodate different patient anatomies and implant fixture sizes, allowing for precise customization during surgical placement by a trained dental professional. The manufacturer’s documentation would provide the full range of available options.

How should the EM Provisional Implant be stored before use, and what are the sterility guarantees?

The EM Provisional Implant is supplied in a sterile condition, suitable for immediate use in a dental office or clinic setting. Since it is single-use, proper storage involves maintaining its sterile packaging until the time of use. The manufacturer ensures sterility to meet dental implant standards, but specific storage instructions (e.g., temperature, humidity) would be outlined in the accompanying documentation to preserve its integrity until deployment.

Can the EM Provisional Implant be used with any dental implant fixture, or are there compatibility requirements?

The EM Provisional Implant is designed to connect with dental implant fixtures using a one-body connection, ensuring stability and alignment. While it is not explicitly restricted to specific implant brands, compatibility depends on the implant system’s platform diameter and connection type. The RBM surface and one-body design are optimized for early bone integration, so the implant fixture must support these features. Clinicians should verify compatibility with their chosen implant system before 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: EM Provisional Implant - eshop.hiossen.com, EM Implant System - Hiossen® Implant, Em Provisional 510 (k) FDA Premarket Notification K191751 Hiossen, Inc., EM Provisional — FDA 510 (k) K191751 | MedTracker, PDF December 16, 2019 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hiossen, Inc.

Sources (1)

  • FDA 510(k) K191751 24 fields · synced Sep 19, 2026