Astra Tech Implant System

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

510(k) Number

K111287 ↗

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 restorations can the Astra Tech Implant System support, and how does it accommodate different patient needs?

  The Astra Tech Implant System supports single-tooth and multi-tooth restorations with flexible restorative options, including cement-retained, screw-retained, and attachment-retained prostheses. This versatility allows clinicians to choose the most suitable approach based on patient anatomy, oral health, and aesthetic preferences, ensuring both function and natural-looking results.

• Is the Astra Tech Implant System designed for one-stage or two-stage surgical procedures, and how does this flexibility benefit patients?

  The Astra Tech Implant System is compatible with both one-stage and two-stage surgical protocols, giving clinicians the flexibility to choose the approach that best fits the patient’s healing profile and clinical needs. One-stage procedures reduce the number of surgeries, while two-stage procedures may offer better control over osseointegration and healing.

• How is the Astra Tech Implant System supplied, and what does this mean for clinical workflow and infection control?

  The Astra Tech Implant System components are supplied sterile for single-use only, which minimizes the risk of cross-contamination and ensures optimal infection control in the operating environment. This also streamlines clinical workflow by eliminating the need for sterilization between patients, as each component is intended to be used once and discarded.

• What regulatory pathway was followed for FDA clearance of the Astra Tech Implant System, and what does this mean for its safety and equivalence?

  The Astra Tech Implant System received FDA 510(k) clearance under a traditional review process, with a decision classification of *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared dental implant system, ensuring it meets established safety and effectiveness standards for dental implants.