Cs 8100 Cs 8100 Access

• • Terminated Z-1377-2015 FDA Class II ·initiated 8 Jan 2015

  Units device head descended unexpectedly

510(k) Number

K120975 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• CS 8100SC, CS8100SC Access

  Class II

  FDA 510(k) K151087 Active Cleared 21 Aug 2015

• CS Imaging

  Class II

  FDA 510(k) K173622 Active Cleared 16 Jan 2018

• Cs 9600 Open recall

  Class II

  FDA 510(k) K200183 Active Cleared 13 Mar 2020

• CS 3D Imaging

  Class II

  FDA 510(k) K151837 Active Cleared 19 Aug 2015

• Cs 8100 3D

  Class II

  FDA 510(k) K133406 Active Cleared 14 Mar 2014

• Kodak 9000, Kodak 9000 3D

  Class II

  FDA 510(k) K073435 Active Cleared 11 Feb 2008

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