Removable Cuff Abutment

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K984536 ↗

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

• Temporary Gingival Cuff And Impression Post And Implant Analog

  Class II

  FDA 510(k) K001786 Active Cleared 21 Jun 2000

• 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

See all devices from Sulzer Calcitek, Inc. →