DEFCON TSA/TSH Dental Implant System

by Impladent, S.L.

510(k) K092261

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) K092261↗

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 · Abbreviated	NumberK092261	Date23 Jul 2010Cleared	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Withdrawn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: K092261
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, 24 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 DEFCON TSA/TSH Dental Implant System is a threaded, root-form endosseous dental implant system. It consists of titanium commercially pure implants with various diameters and lengths, corresponding abutments, and different implant-to-abutment connection options. The system includes modified surfaces designed to promote improved osseointegration.

The device is intended for single-stage or two-stage surgical procedures and supports cement or screw-retained restorations. It is supplied as a non-sterile, reusable system requiring sterilization prior to use. The system is authorized under FDA 510(k) clearance K092261 with product code DZE and is classified under the dental advisory committee.