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Straumann Surgical Cassettes

by Straumann USA, LLC

510(k) K203753

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203753 Date29 Jul 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Straumann Surgical Cassettes are modular surgical kits designed for use with all Straumann implant lines. These cassettes provide a straightforward and organized workflow with a lean instrument portfolio.

The cassettes contain functional, reliable, and easy-to-handle surgical instruments that help clinicians effectively manage challenging clinical cases. They are supplied as sterile, single-use devices and are intended for use in hospital settings. The device has FDA 510(k) clearance with product code KCT.

Other devices from Straumann USA

See all devices from Straumann USA →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical situations are Straumann Surgical Cassettes intended for?

    The cassettes are meant for hospital‑based implant surgery using any Straumann implant system. Their organized instrument set helps clinicians manage complex cases by providing the essential tools in a single, ready‑to‑use package.

  • Are the cassettes supplied sterile and for single use only?

    Yes, each cassette is delivered sterile and is labeled for single‑use only. This ensures a contamination‑free environment for each procedure and eliminates the need for re‑processing, which can save time and reduce infection risk.

  • What types of instruments are included in the cassette?

    The cassette contains a curated portfolio of functional, reliable surgical instruments that are easy to handle. While the exact list varies by kit, the instruments are selected to cover the essential steps of implant placement across all Straumann product lines.

  • How is the cassette packaged and stored before use?

    Cassettes are packaged in a sealed, sterile wrapper that maintains sterility until the point of opening in the operating room. They should be stored in a controlled environment, typically at room temperature, away from moisture and direct sunlight to preserve their integrity.

  • What regulatory clearance does the device have?

    Straumann Surgical Cassettes have received FDA 510(k) clearance under product code KCT, indicating they are substantially equivalent to a legally marketed predicate device. This clearance confirms that the cassettes meet the necessary safety and performance standards for their intended use.