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HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241003

by Hiossen, Inc.

Identifiers

510(k) Number
K241003 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 Hiossen Pre-milled Abutment is classified as a dental abutment, a component used in dental implantology to connect an implant fixture to a prosthetic crown, bridge, or overdenture. These abutments are pre-manufactured to standard dimensions and designed to interface with Hiossen dental implants, facilitating the placement of custom prosthetic restorations. Constructed from titanium, they provide mechanical stability and biocompatibility for long-term use in oral rehabilitation. The ET and EK variants are tailored for specific implant systems, ensuring compatibility and predictable outcomes in restorative dentistry.

These abutments are supplied as single-use, sterile components intended for use in clinical settings by dental professionals. They are compatible with Hiossen’s dental implant systems and require no additional milling beyond standard prosthetic fabrication. The devices are regulated under FDA 510(k) clearance (K241003) as substantially equivalent to predicate devices, adhering to dental implant standards. Storage should follow manufacturer guidelines to maintain sterility and integrity until use. No MRI safety information is specified, and sizing is predefined by the ET and EK models.

Frequently asked questions

What is the Hiossen Pre-milled Abutment used for?

The Hiossen Pre-milled Abutment (ET and EK variants) connects dental implant fixtures to prosthetic crowns, bridges, or overdentures. It provides a stable interface for custom restorations in oral rehabilitation, ensuring predictable outcomes by matching Hiossen’s implant systems. The titanium construction ensures long-term biocompatibility and mechanical stability.

Are these abutments single-use or reusable?

These abutments are designed for single-use only. They are supplied sterile and intended for clinical use by dental professionals, eliminating the need for sterilization between patients. This approach ensures patient safety and maintains the integrity of the device.

What materials are the ET and EK Pre-milled Abutments made from?

Both the ET and EK Pre-milled Abutments are constructed from titanium, a material known for its biocompatibility and durability in dental applications. Titanium’s properties reduce the risk of adverse reactions and provide the mechanical strength required for long-term implant stability.

How should these abutments be stored to maintain sterility?

Storage should follow the manufacturer’s guidelines to preserve sterility and structural integrity until use. The abutments are packaged as sterile components, so they must remain unopened and protected from contamination until clinical application. Avoid exposure to moisture, extreme temperatures, or physical damage.

Are there specific sizing options for the ET and EK models?

The ET and EK Pre-milled Abutments are pre-manufactured to predefined standard dimensions, tailored specifically for compatibility with Hiossen’s implant systems. No additional milling is required beyond standard prosthetic fabrication. The distinction between ET and EK models ensures proper fitment within their respective implant systems.

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: Prosthetics - Pre-milled Abutment - Hiossen eShop, PDF January 8, 2025 Hiossen, Inc. ℅ Ankur Naik Managing Director IZiel ..., HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hiossen, Inc.

Sources (1)

  • FDA 510(k) K241003 24 fields · synced Oct 1, 2026