Dental Implant

• • Terminated Z-2314-2016 FDA Class II ·initiated 18 Jul 2016

  Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

510(k) Number

K992937 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite

  Class II

  FDA 510(k) K023952 Active Cleared 16 Jan 2003

• Procera Preparable Abutment System

  Class II

  FDA 510(k) K974150 Active Cleared 23 Jan 1998

• Nobel Perfect Implant System

  Class II

  FDA 510(k) K030257 Active Cleared 10 Feb 2003

• Replace Ha Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

  Class II

  FDA 510(k) K020646 Active Cleared 29 May 2002

• Inplant Orthodontic Anchor System

  Class II

  FDA 510(k) K000643 Active Cleared 7 Sep 2000

• Branemark System(R) Ebon(Tm) Fixture

  Class II

  FDA 510(k) K974828 Active Cleared 24 Mar 1998

See all devices from Nobel Biocare Uas, Inc. →