Osseospeed Narrow

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

510(k) Number

K080396 ↗

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 types of dental procedures is the Osseospeed Narrow implant designed for, and why is its narrow profile important?

  The Osseospeed Narrow implant is designed for osseointegration within the alveolar bone to support prosthetic restorations in dental rehabilitation. Its narrow profile is specifically engineered to fit anatomical constraints where space is limited, ensuring precise placement and optimal integration with surrounding bone tissue. This design helps clinicians achieve stability in areas where wider implants might not be feasible.

• Is the Osseospeed Narrow implant reusable, or is it intended for single-use only? What does this mean for clinical workflow?

  The Osseospeed Narrow implant is explicitly intended for single-use only and is supplied sterile. This eliminates the need for sterilization or reprocessing after use, simplifying clinical workflows and reducing the risk of cross-contamination. Clinicians can proceed directly with implantation without additional preparation steps.

• What connection mechanism does the Osseospeed Narrow implant use, and how does it benefit the patient?

  The Osseospeed Narrow implant features a Morse taper platform-to-abutment connection with anti-rotation mechanisms, which enhances stability and minimizes micromotion. This design reduces the risk of implant loosening or failure over time, contributing to long-term success and patient comfort by ensuring a secure foundation for prosthetic restorations.

• How is the Osseospeed Narrow implant regulated, and what does this mean for clinicians using it?

  The Osseospeed Narrow implant holds FDA 510(k) clearance (K080396) under the Dental (DE) advisory committee, classified as substantially equivalent to prior devices. This means it meets U.S. regulatory standards for safety and effectiveness, allowing clinicians to use it with confidence in procedures requiring dental implants. The clearance also ensures compliance with biocompatibility and structural integrity requirements.

• Are there different sizes or models available for the Osseospeed Narrow implant, and how might this affect patient selection?

  While the provided data does not specify exact sizes or models, the Osseospeed Narrow is explicitly designed for narrow anatomical constraints, implying availability in varying lengths or diameters to accommodate different patient anatomies. Clinicians should consult the manufacturer’s sizing guides to select the appropriate implant for each case, ensuring optimal fit and integration.