Digora Optime (or Digora Ontime)

• 4 recalls, same reason

  • Terminated Z-0839-2020 FDA Class II ·initiated 7 Jan 2020 ·on shared 510(k) K041050
  • Terminated Z-0841-2020 FDA Class II ·initiated 7 Jan 2020 ·on shared 510(k) K041050
  • Terminated Z-0842-2020 FDA Class II ·initiated 7 Jan 2020 ·on shared 510(k) K041050
  • Terminated Z-0840-2020 FDA Class II ·initiated 7 Jan 2020 ·on shared 510(k) K041050

  Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K041050 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Scanora 3D

  Class II

  FDA 510(k) K110839 Active Cleared 30 Jun 2011

• Digora Pct

  Class II

  FDA 510(k) K012170 Active Cleared 10 Aug 2001

• Minray

  Class II

  FDA 510(k) K033755 Active Cleared 29 Apr 2004

• Digora Pct/Digipod

  Class II

  FDA 510(k) K070304 Active Cleared 27 Mar 2007

• Cranex Basex D or Cranex Excel D

  Class II

  FDA 510(k) K040382 Active Cleared 13 Jul 2004

• Cranex Novus

  Class II

  FDA 510(k) K063459 Active Cleared 26 Dec 2006

See all devices from Soredex Palodex Group OY →