Abutment Retrieval Kit

• • Terminated Z-1324-2020 FDA Class II ·initiated 14 Mar 2019

  Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

510(k) Number

K955697 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Branemark System 17 Angulated Abutment

  Class II

  FDA 510(k) K944962 Active Cleared 27 Feb 1995

• Branemark System

  Class II

  FDA 510(k) K934825 Active Cleared 8 Aug 1994

• Branemark System Estheticone Abutment Complete

  Class II

  FDA 510(k) K925777 Active Cleared 14 Apr 1993

• Branemark System-3.0mm Fixture

  Class II

  FDA 510(k) K911960 Active Cleared 19 Dec 1991

• Miruscone Abutment System

  Class II

  FDA 510(k) K961728 Active Cleared 10 Jul 1996

• Branemark System Single Tooth Abutments, Inst&Comp.

  Class II

  FDA 510(k) K925767 Active Cleared 20 Oct 1993

See all devices from Nobelpharma USA, Inc. →