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Atlantis Conus Structure

by Dentsply Sirona 510(k)

Active United States

510(k) K181189

Overview

The Atlantis Conus Structure is a patient-specific prosthetic solution designed for dental implant applications. It provides a conometric retention system that enables removable prostheses with the stability and comfort of fixed restorations.

This device is supplied as part of digital prosthetic solutions for major implant systems. It is intended for use in dental settings and is authorized under FDA 510(k) clearance K181189 with product code NHA.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181189 Date18 Jul 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • 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 Conus Structure used for?

    The ATLANTIS Conus Structure is a patient-specific prosthetic solution designed for dental implant applications. It provides a conometric retention system that enables removable prostheses with the stability and comfort of fixed restorations.

  • How is the ATLANTIS Conus Structure supplied?

    This device is supplied as part of digital prosthetic solutions for major implant systems. It is intended for use in dental settings and is authorized under FDA 510(k) clearance K181189 with product code NHA.

  • What regulatory approval does the ATLANTIS Conus Structure have?

    The ATLANTIS Conus Structure is authorized under FDA 510(k) clearance K181189 with product code NHA. It received FDA clearance on July 18, 2018, after being submitted on May 3, 2018.

  • Is the ATLANTIS Conus Structure reusable or single-use?

    The device information does not specify whether the ATLANTIS Conus Structure is designed for single-use or reuse. For proper handling and reuse instructions, please consult the manufacturer's guidelines or product documentation.