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5.0 X 5mm Endopore Endosseous Dental Implant System

by Innova Life Sciences Corp.

510(k) K032140

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 NumberK032140 Date2 Oct 2003ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

This device is an endosseous, root-form dental implant used to support dental prostheses in the upper or lower jaw. It consists of a root component, collar, screws, and healing cap or overdenture abutment, featuring a truncated conical design with tapered sides.

The implant is surgically placed by a dentist using a standard two-stage procedure. It is supplied as a sterile, single-use device and is intended for use in dental clinical settings. The device has received FDA 510(k) clearance under product code DZE and is classified as a Class II medical device.

Other devices from Innova Life Sciences Corp.

Questions

AI-generated answers, 25 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 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM used for?

    It is used to support dental prostheses in the upper or lower jaw by serving as an endosseous, root-form implant that integrates with bone to anchor crowns, bridges, or dentures.

  • How is the 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM supplied and is it reusable?

    It is supplied as a sterile, single-use device in a sealed package, intended for one-time surgical implantation only; reuse is not permitted due to risk of contamination, material degradation, and loss of sterility.

  • What components are included with the 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM?

    The system includes a root component, collar, screws, and either a healing cap or overdenture abutment, all designed with a truncated conical shape and tapered sides for optimal soft tissue and bone integration.

  • What surgical procedure is required to place the 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM?

    It is placed using a standard two-stage surgical procedure: first, the implant is inserted into the jawbone and allowed to osseointegrate; second, after healing, the abutment and prosthesis are attached.