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HT III SA Fixture System

by Hiossen, Inc.

510(k) K101096

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 NumberK101096 Date8 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  • Withdrawn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, 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 HT III SA Fixture System is an implant, endosseous, root-form device classified under product code DZE. It features a sand-blasted and acid-etched (SA) surface with an internal hex connection. This system is designed for dental implant procedures.

The HT III SA Fixture System is manufactured by Hiossen, Inc. and received FDA 510(k) clearance on October 8, 2010. It is supplied as a Class II device with special controls. The system is manufactured and packaged in Pennsylvania, USA.

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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 HT III SA Fixture System used for?

    The HT III SA Fixture System is an implant, endosseous, root-form device designed specifically for dental implant procedures. It features a sand-blasted and acid-etched surface with an internal hex connection to facilitate secure placement in the jawbone.

  • How is the HT III SA Fixture System supplied?

    The system is supplied as a Class II device with special controls. It is manufactured and packaged in Pennsylvania, USA by Hiossen, Inc. Each unit is designed for dental implant procedures and comes with the necessary specifications for professional use.

  • What is the regulatory status of the HT III SA Fixture System?

    The HT III SA Fixture System received FDA 510(k) clearance on October 8, 2010, with decision code SESE (Substantially Equivalent). It is classified under product code DZE and was reviewed by the Dental advisory committee (DE).

  • What are the key features of the HT III SA Fixture System?

    The HT III SA Fixture System features a sand-blasted and acid-etched (SA) surface that promotes osseointegration, and an internal hex connection for stability during and after implantation. These design elements are intended to enhance the success rate of dental implant procedures.