Dyna Torq Torque Wrench, Torque Wrench

• • Terminated Z-1212-2010 FDA Unclassified (pre-2012) ·initiated 19 Jan 2009

  Pro-Dex has initiated a recall on their Dental Torque Wrench. The recall was initiated due to an inaccurate laser etch identification of the torque value.

510(k) Number

K991283 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Pro-Torq

  Class I

  FDA 510(k) K000120 Active Cleared 3 Feb 2000

• 29540 Dynasurg Electric Handpiece and Irr. System

  Class I

  FDA 510(k) K911068 Active Cleared 15 May 1991

• Micro Rsh High Speed Handpiece

  Class I

  FDA 510(k) K935676 Active Cleared 31 Mar 1995

• Oral Surgery Handpiece and Attachments

  Class I

  FDA 510(k) K896879 Active Cleared 7 Mar 1990

• Dynatorq Dental Handpiece Attachments

  Class I

  FDA 510(k) K896876 Active Cleared 7 Mar 1990

• Dynasonic Plaque Remover & Polisher Dynatip

  Class II

  FDA 510(k) K903298 Active Cleared 16 Apr 1991

See all devices from Micro Motors, Inc. →