Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant

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

510(k) Number

K112138 ↗

FDA Product Code

NHA

Device Class

Class II

Regulation

21 CFR Part 872.3630

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 primary material of the Atlantis Abutment in Zirconia, and why is it significant for patients?

  The Atlantis Abutment in Zirconia is constructed from yttria-stabilized tetragonal zirconia polycrystals (-Y-TZP), a biocompatible ceramic material. This is significant for patients because zirconia offers an aesthetic, non-metallic alternative to traditional metal abutments, reducing the risk of metal allergies or visible metal lines at the gumline while maintaining durability and biocompatibility.

• Is this abutment designed for reuse or single-use, and how should it be stored to maintain sterility?

  This abutment is intended for single-use only and is supplied sterile. To preserve sterility and functionality, storage and handling should strictly follow standard dental implant protocols, such as keeping it in its original packaging until immediate use and avoiding contamination from moisture or direct contact with unsterile surfaces.

• Which Astra Tech implant systems is this abutment compatible with, and what implant diameters does it support?

  The Atlantis Abutment in Zirconia is specifically designed for use with the Astra Tech Osseospeed Plus implant system. It is compatible with implant diameters of 3.6mm and 4.2mm, ensuring a secure connection for dental prosthetics like crowns or bridges.

• What regulatory pathway does this device follow, and what standards does it adhere to?

  This abutment follows the FDA 510(k) clearance pathway, with a clearance number of K112138, and is classified under Product Code NHA (Dental Abutment). It adheres to ISO 6972 standards for yttria-stabilized tetragonal zirconia polycrystals (-Y-TZP), ensuring compliance with established material and performance requirements for dental implants.