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4.0MM Simpler Threaded Dental Implant

by Vancouver Implant Resources, Inc.

510(k) K974857

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 NumberK974857 Date27 Feb 1998ClearedStatusActive

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  • Withdrawn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.

The 4.0mm Simpler Threaded Dental Implant is an intra-bony support structure for dental prosthetics. It is surgically placed into the jawbone to provide an anchor for crowns, bridges, or overdentures. This device functions to restore function and aesthetics for patients with missing teeth.

The implant is supplied as a single-use device and is intended for use by dental professionals in a clinical setting. It has FDA 510(k) clearance with product code DZE and was cleared through the Traditional 510(k) pathway after a 60-day FDA review. The device is available in a 4.0mm size.

Other devices from Vancouver Implant Resources, Inc.

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 4.0mm Simpler Threaded Dental Implant used for?

    The 4.0mm Simpler Threaded Dental Implant is an intra-bony support structure surgically placed into the jawbone to provide an anchor for dental prosthetics such as crowns, bridges, or overdentures, restoring function and aesthetics for patients with missing teeth.

  • Is the 4.0mm Simpler Threaded Dental Implant a single-use device?

    Yes, the 4.0mm Simpler Threaded Dental Implant is supplied as a single-use device and is intended for use by dental professionals in a clinical setting.

  • What regulatory clearance does the 4.0mm Simpler Threaded Dental Implant have?

    The 4.0mm Simpler Threaded Dental Implant has FDA 510(k) clearance with product code DZE and was cleared through the Traditional 510(k) pathway after a 60-day FDA review.

  • What sizes are available for the Simpler Threaded Dental Implant?

    The Simpler Threaded Dental Implant is available in a 4.0mm size, designed to provide intra-bony support for dental prosthetics.