Hex-Lock Temporary Abutment

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

510(k) Number

K014050 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Sulzer Dental Ceramic System-Spline

  Class II

  FDA 510(k) K014214 Active Cleared 19 Mar 2002

• 3.75mm and 5.0mm Spline Twist Implant

  Class II

  FDA 510(k) K013494 Active Cleared 18 Jan 2002

• Sulzer Dental Ceramic System-Hexlock

  Class II

  FDA 510(k) K014175 Active Cleared 20 Mar 2002

• 3.25mm Spline Twist Implant

  Class II

  FDA 510(k) K012055 Active Cleared 6 Sep 2001

• Advent Implant System, Swiss Plus Implant System

  Class II

  FDA 510(k) K011245 Active Cleared 25 Jun 2001

• Taper-Lock Dental Implant System

  Class II

  FDA 510(k) K011038 Active Cleared 15 May 2001

See all devices from Sulzer Dental, Inc. →

• What is the Hex-Lock Temporary Abutment used for?

  The Hex-Lock Temporary Abutment is designed for use on the internal hexagon implant interface for less than twenty-eight days. It is placed in the edentulous mandibles or maxillae for fixation of a final crown during temporary dental applications.

• Is the Hex-Lock Temporary Abutment single-use or reusable?

  The Hex-Lock Temporary Abutment is supplied as either a single-use or reusable product, depending on the specific configuration selected by the clinician for temporary dental applications.

• What is the regulatory status of the Hex-Lock Temporary Abutment?

  The Hex-Lock Temporary Abutment is authorized under FDA 510(k) number K014050 with product code DZE and is regulated for dental specialty use, having been determined substantially equivalent to predicate devices.

• How long can the Hex-Lock Temporary Abutment be used?

  The Hex-Lock Temporary Abutment is designed for temporary use of less than twenty-eight days on the internal hexagon implant interface before replacement with a permanent restoration.