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Atlantis Abutment for Mis Conical Connection Implants

by Dentsply Sirona 510(k)

Active United States

510(k) K193529

Overview

The Atlantis Abutment for Mis Conical Connection Implants is a dental abutment used to support a cement-retained crown or bridge with an endosseous implant. It is available in various materials, including titanium, gold-shaded titanium, and zirconia. The abutment is designed for use with specific implant systems. It is a component used in dental restorations.

The Atlantis Abutment for Mis Conical Connection Implants is supplied by Dentsply Sirona and has received FDA 510K authorization. The device is used in dental settings to provide patient-specific solutions. It is part of the Atlantis product line, which offers customized abutments for various implant systems.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193529 Date5 Mar 2020ClearedStatusActive

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 Abutment for MIS Conical Connection Implants used for?

    This abutment is designed to support cement-retained crowns or bridges in dental restorations. It connects to endosseous implants, providing a stable foundation for prosthetic teeth. The conical connection ensures a secure fit, which is particularly useful in minimally invasive surgery (MIS) procedures where precision and stability are critical.

  • What materials are available for the Atlantis Abutment?

    The abutment is available in three materials: titanium, gold-shaded titanium, and zirconia. Titanium offers strength and biocompatibility, gold-shaded titanium provides an aesthetic match for certain implant systems, and zirconia delivers a metal-free option with natural tooth-like appearance and durability. The choice depends on clinical needs, patient preferences, and the specific implant system being used.

  • Is the Atlantis Abutment single-use or reusable?

    The Atlantis Abutment is intended for single-use in dental procedures. Single-use devices minimize cross-contamination risks and ensure patient safety by eliminating the need for sterilization between patients. Always follow manufacturer guidelines for proper handling and disposal to maintain clinical standards.

  • How is the Atlantis Abutment supplied, and what should I consider when ordering?

    The abutment is supplied by Dentsply Sirona as part of their Atlantis product line, which offers customized solutions for various implant systems. When ordering, ensure compatibility with your chosen implant system and confirm the material (titanium, gold-shaded titanium, or zirconia) to match your clinical requirements. The conical connection design must align with the implant system’s specifications for proper fit and function.

  • What regulatory approval does the Atlantis Abutment hold?

    The Atlantis Abutment for MIS Conical Connection Implants has received FDA 510K authorization, indicating it is deemed substantially equivalent to a legally marketed predicate device. This approval ensures it meets U.S. regulatory standards for safety and effectiveness in dental applications. Always verify the latest regulatory status with the manufacturer or relevant authorities.