Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in Zirconia for Astra Implants

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

510(k) Number

K072483 ↗

FDA Product Code

NHA

Device Class

Class II

Regulation

21 CFR Part 872.3630

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia

  Class II

  FDA 510(k) K052070 Active Cleared 14 Oct 2005

• Atlantis Abutment in Zirconia for 3I Certain Interface

  Class II

  FDA 510(k) K063734 Active Cleared 2 Mar 2007

• Atlantis Abutment for Astra Implant

  Class II

  FDA 510(k) K070833 Active Cleared 22 Jun 2007

• Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants

  Class II

  FDA 510(k) K071946 Active Cleared 5 Oct 2007

• Atlantis Abutment for 3I Micromini Implant

  Class II

  FDA 510(k) K062069 Active Cleared 14 Feb 2007

• Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ Abutment

  Class II

  FDA 510(k) K062197 Active Cleared 28 Feb 2007

See all devices from Atlantis Components, Inc. →

• What are the Atlantis Zirconia Abutments used for?

  The Atlantis Zirconia Abutments are designed as connectors between dental implants and prosthetic crowns or bridges. They provide a stable foundation for cement-retained restorations, ensuring proper alignment and function. The abutments are specifically tailored for use with 3I Certain Microamini Implants and Astra Implants, ensuring compatibility with these implant systems.

• Are these abutments single-use or reusable?

  These abutments are supplied as single-use components. They are intended for one-time clinical use to maintain sterility and prevent cross-contamination. The manufacturer-provided packaging ensures they remain sterile until use, eliminating the need for additional sterilization.

• Do these abutments require any special handling or storage?

  Yes, these abutments require careful handling to preserve sterility before use. They are packaged for single-use and should be stored according to the manufacturer’s instructions, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid opening the packaging until immediate clinical use.

• Are the Atlantis Zirconia Abutments MRI-safe?

  No, these abutments are not MRI-safe. If MRI imaging is required for a patient with these components, the clinician must consult the manufacturer’s guidelines and ensure compatibility with the MRI machine settings to avoid potential risks.

• What regulatory approvals do these abutments have?

  These abutments hold FDA clearance under the 510(k) pathway, with clearance number K072483. This confirms their regulatory compliance for dental use in the United States, demonstrating substantial equivalence to a predicate device as determined by the FDA.