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Atlantis Abutment for Straumann Interface

by Atlantis Components, Inc. 510(k)

Active United States

510(k) K050052

Overview

The Atlantis Abutment for Straumann Interface is a dental implant abutment classified under the Abutment, Implant, Dental, Endosseous nomenclature. It serves as a custom-fabricated component designed to connect prosthetic crowns or restorations to Straumann dental implants, ensuring precise fit and stability for long-term dental rehabilitation.

This abutment is manufactured from titanium alloy (Ti-6Al-4V ELI) and is intended for use as an accessory to Straumann endosseous implants. It is supplied as a single-use component, placed directly over the implant shoulder to facilitate prosthetic attachment. The device is regulated under FDA 510(k) clearance (K050052) and falls under the NHA product code for dental implant abutments and prosthetic components.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050052 Date7 Mar 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Atlantis Abutment for Straumann Interface used for in dental procedures?

    The Atlantis Abutment for Straumann Interface is a custom-fabricated dental component designed to connect prosthetic crowns or restorations to Straumann dental implants. It sits directly on the implant shoulder, ensuring a precise and stable fit to support long-term dental rehabilitation by acting as a critical link between the implant and the final restoration.

  • Is the Atlantis Abutment for Straumann Interface meant to be reused or is it single-use?

    The Atlantis Abutment for Straumann Interface is explicitly supplied as a single-use component. This design ensures patient safety and sterility, as it is intended to be placed once and discarded after use, preventing cross-contamination or degradation from repeated sterilization.

  • What material is the Atlantis Abutment for Straumann Interface made from, and why does that matter?

    The abutment is manufactured from titanium alloy (Ti-6Al-4V ELI), a biocompatible material known for its strength, corrosion resistance, and compatibility with human tissue. This material choice is critical for dental implants, as it minimizes allergic reactions, ensures durability, and supports osseointegration—the process where bone grows directly into the implant for stability.

  • How is the Atlantis Abutment for Straumann Interface regulated in the U.S.?

    The device is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K050052. It was determined to be *substantially equivalent* to a legally marketed predicate device and falls under the NHA product code for dental implant abutments and prosthetic components. This classification ensures it meets U.S. safety and performance standards for dental implant accessories.