Temporary Gingival Cuff And Impression Post And Implant Analog

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K001786 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Spline Dental Implant System - Spline XI Implant

  Class II

  FDA 510(k) K981562 Active Cleared 30 Jul 1998

• Edosseous Dental Implant

  Class II

  FDA 510(k) K970127 Active Cleared 23 Jun 1997

• Spline Dental Implant System-Temporary Abutment

  Class II

  FDA 510(k) K982305 Active Cleared 22 Sep 1998

• Threadloc Dental Implant Systems

  Class II

  FDA 510(k) K964768 Active Cleared 25 Feb 1997

• Spline Engaging Shouldered Abutment System

  Class II

  FDA 510(k) K970752 Active Cleared 23 Jun 1997

• Spline Dental Implant System

  Class II

  FDA 510(k) K010073 Active Cleared 19 Jan 2001

See all devices from Sulzer Calcitek, Inc. →

• What is the primary function of this dental device?

  This device is designed to assist in the restorative process for dental implants. It serves a dual purpose by managing gingival tissue during the healing phase and acting as a component to capture accurate impressions required for prosthetic fabrication.

• What is the regulatory status of this device?

  This device has received FDA 510(k) clearance under K001786. It is categorized under product code DZE for use in dental clinical settings and has been determined to be substantially equivalent to existing devices.

• Who is the manufacturer of this implant component?

  This device is manufactured by Sulzer Calcitek, Inc., located in Carlsbad, California. The company received clearance for this product in June 2000.