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ET III Bio-SA Fixture System

by Hiossen, Inc.

510(k) K151626

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151626 Date21 Jul 2016ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1604-2023 FDA Class II initiated 6 Apr 2023

    Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm

Timeline

2 dated events

  1. Cleared FDA 510(k) K151626
  2. Recall initiated FDA recalls Z-1604-2023

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 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 ET III Bio-SA Fixture System is a dental implant fixture classified under the nomenclature category DZE (Dental Implant Fixture). It is designed for use in partially or fully edentulous mandibles and maxillae, providing a stable foundation for dental prosthetics. The system features a sand-blasted and acid-etched (SA) surface to enhance osseointegration and an internal hex connection for secure attachment.

This system is supplied as a sterile, single-use device intended for surgical placement by dental professionals. It is regulated under the FDA 510(k) clearance (K151626) and falls under the Dental Advisory Committee (DE) review panel. The fixture is intended for use in controlled clinical settings and must be handled according to standard aseptic techniques. No additional regulatory markings beyond the FDA clearance are stated.

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