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Biohex One-Piece One Stage Dental Implant System

by Biomedical Implant Technology, Inc.

510(k) K013383

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 NumberK013383 Date10 Jan 2002ClearedStatusActive

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  • Withdrawn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, 26 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 Biohex One-Piece One Stage Dental Implant System is a dental implant device designed for tooth replacement. It features a one-piece design that allows for single-stage implant procedures and immediate loading.

The system is supplied as a single-stage implant and restoration procedure, designed to save time and money during dental procedures. It is authorized under FDA 510K clearance with product code DZE and model number K013383.

Other devices from Biomedical Implant Technology, Inc.

Questions

AI-generated answers, 26 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 Biohex One-Piece One Stage Dental Implant System used for?

    The Biohex One-Piece One Stage Dental Implant System is designed for tooth replacement, featuring a one-piece design that allows for single-stage implant procedures and immediate loading to save time during dental procedures.

  • How is the Biohex One-Piece One Stage Dental Implant System supplied?

    The system is supplied as a single-stage implant and restoration procedure, designed to streamline dental procedures and reduce both time and costs associated with tooth replacement treatments.

  • What is the regulatory status of the Biohex One-Piece One Stage Dental Implant System?

    The Biohex One-Piece One Stage Dental Implant System is authorized under FDA 510K clearance with product code DZE and model number K013383, having been determined substantially equivalent to predicate devices.

  • What are the key features of the Biohex One-Piece One Stage Dental Implant System?

    The key features include its one-piece design that enables single-stage implant procedures and immediate loading capabilities, making it an efficient option for dental professionals performing tooth replacement surgeries.