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Endosseous Dental Implant

by Southern Implants, Inc.

510(k) K093562

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 NumberK093562 Date14 Oct 2010ClearedStatusActive

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  • Withdrawn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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

An endosseous dental implant is a medical device designed to be placed within the jawbone to support dental prostheses. This implant serves as an anchor for artificial teeth, providing stability and function similar to natural tooth roots. The device is intended for use in dental restoration procedures to replace missing teeth.

The endosseous dental implant is supplied as a sterile device and is designed for single-use. It is available in various sizes and models to accommodate different clinical needs. The device has received FDA 510(k) clearance with the product code DZE and is classified under the advisory committee for dental devices.

Other devices from Southern Implants, Inc.

Questions

AI-generated answers, 21 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 purpose of an endosseous dental implant?

    An endosseous dental implant is designed to be placed within the jawbone to serve as an anchor for dental prostheses, providing stability and function similar to natural tooth roots in dental restoration procedures.

  • How is the endosseous dental implant supplied?

    The endosseous dental implant is supplied as a sterile device and is designed for single-use. It is available in various sizes and models to accommodate different clinical needs.

  • What regulatory clearance has this implant received?

    The endosseous dental implant has received FDA 510(k) clearance with the product code DZE and is classified under the advisory committee for dental devices.

  • Can the endosseous dental implant be reused?

    No, the endosseous dental implant is designed for single-use only and should not be reused to ensure patient safety and device performance.