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Atlas Implant System Mini Plus

by Cowellmedi Co., Ltd

510(k) K090049

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090049↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK090049 Date20 Apr 2009ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DZE
FDA applicant
Cowellmedi Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 872.3640
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Atlas Implant System Mini Plus is an endosseous root-form dental implant, classified under the product code DZE. It is designed for surgical placement into the bone of the maxilla or mandible to provide temporary support for provisional prosthetic devices during the healing phase of permanent dental implants.

This device is intended for immediate loading in partially or fully edentulous patients. It is supplied as a reusable surgical implant, with no indication of sterility or MRI safety in the provided data. The system is authorised under FDA 510(k) clearance (K090049) and meets the requirements of the Medical Device Directive (MDD).

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Questions

AI-generated answers, 18 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 primary purpose of the ATLAS IMPLANT SYSTEM-MINI PLUS, and who is it intended for?

    The ATLAS IMPLANT SYSTEM-MINI PLUS is designed as an endosseous root-form dental implant for surgical placement in the maxilla or mandible. It provides temporary support for provisional prosthetic devices during the healing phase of permanent dental implants. It is specifically intended for immediate loading in patients who are either partially or fully edentulous, meaning those who have lost some or all of their teeth.

  • Is the ATLAS IMPLANT SYSTEM-MINI PLUS intended for single-use or can it be reused?

    The ATLAS IMPLANT SYSTEM-MINI PLUS is explicitly described as a reusable surgical implant. This means it is not designed for single-use and can be used multiple times after appropriate cleaning and sterilization procedures, though the data does not specify sterility or reprocessing guidelines.

  • What regulatory pathways has the ATLAS IMPLANT SYSTEM-MINI PLUS followed for approval?

    The device has been authorized through FDA 510(k) clearance (K090049) under the Traditional review pathway, with a decision classification of *Substantially Equivalent* in the Dental category. It also complies with the Medical Device Directive (MDD) requirements, indicating it meets regulatory standards in both the U.S. and EU markets.

  • Does the ATLAS IMPLANT SYSTEM-MINI PLUS come with any specific size or model variations?

    The provided data does not detail specific size or model variations of the ATLAS IMPLANT SYSTEM-MINI PLUS. However, as an endosseous root-form implant, it is likely available in multiple diameters or lengths to accommodate different patient anatomies. For precise sizing options, consulting the manufacturer’s technical documentation or catalog would be necessary.