Duo-Dent Dental Implant

by Duo-Dent Dental Implant Systems, LLC

510(k) K010386

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

510(k) K010386↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK010386	Date27 Feb 2001Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K010386
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, 22 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 Duo-Dent Dental Implant is a dental implant intended for placement within the jawbone to support prosthetic dental restorations. It is designed as a root-form, endosseous device that integrates with bone tissue to provide a stable foundation for crowns or bridges.

The implant was cleared by the U.S. Food and Drug Administration through a 510(k) special clearance (K010386) and is classified as a Class II device under product code DZE. It is supplied by Duo-Dent Dental Implant Systems, LLC and is subject to the applicable FDA regulations for dental implants.