Star Titan Series Motors & Attachments

• • Terminated Z-2078-2014 FDA Class II ·initiated 13 Jun 2014

  The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.

• • Terminated Z-2354-2010 FDA Unclassified (pre-2012) ·initiated 11 Aug 2010

  The housing of 5K motor is labeled as a 20K motor.

510(k) Number

K960260 ↗

FDA Product Code

EFA

Device Class

Class I

Regulation

21 CFR Part 872.4200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• High Speed Non-Fiber Optic Swivel Handpiece

  Class II

  FDA 510(k) K902402 Active Cleared 29 Aug 1990

• Stardental Titan 3 Lubefree Motor Attachments

  Class I

  FDA 510(k) K983574 Active Cleared 8 Jan 1999

• Portable Hdx Intraoral X-Ray

  Class II

  FDA 510(k) K021378 Active Cleared 7 Jun 2002

• Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus High Speed Dental Handpiece

  Class II

  FDA 510(k) K030133 Active Cleared 29 Apr 2003

• Handpiece Fiber Optic System Improvement Feature

  Class I

  FDA 510(k) K896361 Active Cleared 2 Feb 1990

• Stardental Axcs Sterile Water System

  Class I

  FDA 510(k) K990844 Active Cleared 28 May 1999

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