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Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K182084

by Sweden & Martina S.p.a.

Identifiers

510(k) Number
K182084 FDA 510(k)
FDA Product Code
KCT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is a surgical tray classified under product code KCT, designed as a container for dental surgical drills and tools. It serves to organize, facilitate steam sterilization, and ensure safe transport of instruments between uses in a general hospital setting.

This tray is intended for single-use or reusable applications in dental surgical procedures, adhering to FDA 510(k) clearance under Traditional review (K182084) and complying with the Medical Device Directive (MDD). It is supplied sterile or non-sterile as required, with dimensions and MRI safety not specified in the available data. Storage should follow manufacturer guidelines to maintain integrity and sterility.

Frequently asked questions

What is the primary purpose of the Sweden & Martina Surgical Tray (Model ZSHORTY-INT) in a clinical setting?

The Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is designed to organize dental surgical drills and tools, ensuring they remain contained during steam sterilization and safe transport between uses. Its role is to streamline workflow in general hospital dental procedures by maintaining instrument integrity and accessibility.

Can this tray be reused, or is it intended for single-use only?

The tray is explicitly labeled for single-use or reusable applications, meaning it can be sterilized and used multiple times if properly maintained. The manufacturer’s guidelines must be followed to ensure sterility and functionality for reuse.

How is the tray supplied, and can it be obtained in a sterile or non-sterile version?

The Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is supplied sterile or non-sterile as required, allowing facilities to order it based on their immediate needs. Sterile versions are ideal for immediate use, while non-sterile versions may be sterilized in-house before first use.

What are the key considerations for storing this tray to maintain its integrity?

Storage should follow the manufacturer’s guidelines to preserve the tray’s structural integrity and sterility (if sterile). While specific storage conditions like temperature or humidity aren’t detailed, proper handling—such as avoiding moisture or physical damage—is critical, especially if reused.

What regulatory pathways does this device follow, and how does that affect its use?

The tray is cleared under FDA 510(k) (K182084) via Traditional review and complies with the Medical Device Directive (MDD). This means it meets U.S. and EU regulatory standards for dental surgical trays, ensuring its safety and performance for organized instrument transport and sterilization in general hospital settings.

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: Sweden & Martina Surgical Tray (Model ZSHORTY-INT), Sweden & Martina Surgical Tray (Model ZSHORTY-INT) by Sweden & Martina ..., Sweden & Martina Surgical Tray (Model ZSHORTY-INT), Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sweden & Martina S.p.a.

Sources (2)

  • FDA 510(k) K182084 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026