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FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
15
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1627-2023Class IICS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-rJuly 21, 2021
Z-1000-2013Class IICareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for allSeptember 18, 2012
Z-0999-2013Class IICareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all September 18, 2012
Z-1095-2013Class IICareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended September 18, 2012
Z-1094-2013Class IICareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended September 18, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K193390CS Model+April 2, 2020
K200183CS 9600March 13, 2020
K181136CS 9600May 24, 2018
K173622CS ImagingJanuary 16, 2018
K151087CS 8100SC, CS8100SC AccessAugust 21, 2015
K151837CS 3D ImagingAugust 19, 2015
K141607DENTAL IMAGING SOFTWARESeptember 18, 2014
K133406CS 8100 3DMarch 14, 2014
K120975CS 8100 CS 8100 ACCESSJune 22, 2012
K113419CS IMAGINGFebruary 16, 2012
K103659CS 9300, CS 9300CAugust 18, 2011
K093478KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEMApril 26, 2010
K082972KODAK 9500December 5, 2008
K080889KODAK 9000C EXTRAORAL IMAGING SYSTEMApril 29, 2008
K073435KODAK 9000, KODAK 9000 3DFebruary 11, 2008