Screw Vent Implant; Tapered Screw Vent Implant

• • Terminated Z-3206-2017 FDA Class II ·initiated 10 Jul 2017

  Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

• • Terminated Z-2144-2014 FDA Class II ·initiated 17 Jul 2014

  Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

510(k) Number

K013227 ↗

FDA Product Code

DZE

Models / Variants

Screw Vent Implant

Tapered Screw Vent Implant

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• 3.75mm and 5.0mm Spline Twist Implant

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• Sulzer Dental Ceramic System-Hexlock

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• 3.25mm Spline Twist Implant

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• Advent Implant System, Swiss Plus Implant System

  Class II

  FDA 510(k) K011245 Active Cleared 25 Jun 2001

• Hex-Lock Temporary Abutment

  Class II

  FDA 510(k) K014050 Active Cleared 13 Nov 2002

See all devices from Sulzer Dental, Inc. →