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Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ Abutment

by Atlantis Components, Inc.

510(k) K051652

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051652 Date22 Jul 2005ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Atlantis Abutment, Atlantis Gemini Abutment, and Atlantis Gemini+ Abutment are patient-specific dental abutments designed to support restorative dental procedures. These components are engineered to recreate anatomical contours and provide customized solutions for various implant systems.

These abutments are available in materials including titanium, gold-shaded titanium, and zirconia to accommodate different clinical requirements. The devices are supplied for use in dental laboratory and clinical settings, with design options that support soft-tissue management and functionality. This device is authorized under FDA 510k clearance K051652.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Atlantis Abutment, Gemini, and Gemini+ systems used for?

    These patient-specific dental abutments are designed to support restorative dental procedures. They are engineered to recreate natural anatomical contours and provide customized solutions for various implant systems, assisting with both soft-tissue management and overall functionality.

  • What materials are available for these abutments?

    To accommodate different clinical requirements, these abutments are available in titanium, gold-shaded titanium, and zirconia. These material options allow clinicians to select the most appropriate solution based on the specific needs of the restorative procedure.

  • What is the regulatory status of these dental abutments?

    The Atlantis Abutment, Atlantis Gemini Abutment, and Atlantis Gemini+ Abutment are authorized under FDA 510k clearance K051652. This indicates the devices have been determined to be substantially equivalent to legally marketed predicate devices.