Skip to content

ATLANTIS Abutment for HIOSSEN ET Implant

by Dentsply Sirona

510(k) K160626

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 NumberK160626 Date29 Aug 2016ClearedStatusActive

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  • Withdrawn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, 19 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 for HIOSSEN ET Implant is a dental abutment designed to connect an endosseous implant to a prosthetic crown or bridge. It serves as a critical interface, enabling secure attachment of cement-retained restorations in implant-supported dental reconstructions.

This abutment is supplied as a single-use component, intended for use with the HIOSSEN ET implant system. It is regulated under FDA 510(k) clearance (K160626) and falls under the Dental advisory committee classification. The device is not specified as MRI-safe or reusable, and no sterility or storage conditions are noted in the provided data.

Other devices from Dentsply Sirona Inc

See all devices from Dentsply Sirona Inc →

Questions

AI-generated answers, 19 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 is the Atlantis Abutment for HIOSSEN ET implant used for in dental procedures?

    The Atlantis Abutment for HIOSSEN ET implant is designed as a critical connection point in dental reconstructions. It securely attaches an endosseous implant to a prosthetic crown or bridge, enabling stable placement of cement-retained restorations in implant-supported treatments. This ensures proper alignment and function of the final dental restoration.

  • Is the Atlantis Abutment for HIOSSEN ET implant intended for reuse, or is it meant to be used only once?

    The Atlantis Abutment for HIOSSEN ET implant is explicitly supplied as a single-use component. This designation ensures patient safety and reliability, as reuse could compromise sterility and structural integrity, which are critical for dental implants.

  • How is the regulatory status of this device determined, and which committee was involved?

    The Atlantis Abutment for HIOSSEN ET implant received FDA clearance through a 510(k) submission, classified under the Dental advisory committee (DE). The device was determined to be substantially equivalent to a legally marketed predicate, following a traditional review process. This clearance was granted on August 29, 2016.

  • What should I consider regarding storage or handling of the Atlantis Abutment for HIOSSEN ET implant?

    The provided data does not specify explicit storage conditions or handling instructions for the Atlantis Abutment. However, as a single-use dental component, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use. Always follow manufacturer guidelines for dental implants to ensure optimal performance.