Bi-Centric System

• 5 recalls, same reason

  • Terminated Z-1325-2010 FDA Unclassified (pre-2012) ·initiated 24 Feb 2010
  • Terminated Z-1324-2010 FDA Unclassified (pre-2012) ·initiated 24 Feb 2010
  • Terminated Z-1326-2010 FDA Unclassified (pre-2012) ·initiated 24 Feb 2010
  • Terminated Z-1180-2010 FDA Unclassified (pre-2012) ·initiated 24 Feb 2010
  • Terminated Z-1179-2010 FDA Unclassified (pre-2012) ·initiated 24 Feb 2010

  Magnetic headrests may affect patients with implantable pacemakers and defibrillators.

510(k) Number

K760404 ↗

FDA Product Code

KLC

Device Class

Class I

Regulation

21 CFR Part 872.6250

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Siemens Sirona(R) Dental Chair

  Class I

  FDA 510(k) K863484 Active Cleared 19 Sep 1986

• Orthophos Plus and Orthophos Plus/CD

  Class II

  FDA 510(k) K972249 Active Cleared 12 Sep 1997

• Heliodent Ds

  Class II

  FDA 510(k) K960819 Active Cleared 29 Mar 1996

• Resubmitted Water Purifier for Use W/Dental Treat

  Class I

  FDA 510(k) K901672 Active Cleared 6 Jul 1990

• Sirolux Fantastic

  Class I

  FDA 510(k) K935390 Active Cleared 10 Dec 1993

• Heliodent Md

  Class II

  FDA 510(k) K950030 Active Cleared 3 Feb 1995

See all devices from Pelton & Crane Co. →