Astra Tech Implants-Dental System Fixture Osseospeed

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

510(k) Number

K024111 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia

  Class II

  FDA 510(k) K120338 Active Cleared 5 Jul 2012

• Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel

  Class II

  FDA 510(k) K091920 Active Cleared 28 Sep 2009

• Osseospeed Tm Profile System

  Class II

  FDA 510(k) K080156 Active Cleared 17 Sep 2008

• Modification To: Lofric Plus Single Use Urinary Catheter

  Class II

  FDA 510(k) K012374 Active Cleared 23 Aug 2001

• Modification to Astra Tech Implant - Dental System

  Class II

  FDA 510(k) K990304 Active Cleared 15 Jul 1999

• Atlantis Crown Abutment, Atlantis Gemini +(Tm) Abutment

  Class II

  FDA 510(k) K110356 Active Cleared 10 Jun 2011

See all devices from Astra Tech, Inc. →

• What is the Astra Tech Implants-Dental System Fixture Osseospeed primarily used for in clinical practice?

  The Astra Tech Implants-Dental System Fixture Osseospeed is designed specifically for osseointegration in oral and maxillofacial surgery. This means it is implanted into bone tissue to serve as a stable foundation for prosthetic dental restorations, such as crowns or bridges. It is part of a full dental implant system that includes additional components like impression copings and abutments to complete the restoration process.

• Is the Osseospeed fixture intended for reuse in clinical settings, or is it meant to be used only once?

  The Astra Tech Implants-Dental System Fixture Osseospeed is explicitly intended for single-use in clinical settings. This design ensures patient safety and sterility, as it requires sterile handling to prevent contamination during or after implantation.

• What other components are included when purchasing the Astra Tech Implants-Dental System Fixture Osseospeed?

  The Osseospeed fixture is supplied as part of a comprehensive dental implant system, which includes additional components such as impression copings, abutments, and screwdrivers. These elements work together to facilitate the full process of implant placement, healing, and prosthetic restoration.

• How should the Osseospeed fixture be stored to maintain its integrity before use?

  While the exact storage instructions are not detailed in the provided data, the fixture’s sterile handling requirement implies it should be stored in a clean, dry environment protected from contamination. Since it is single-use, it should remain in its original packaging until ready for clinical use to preserve sterility and functionality.