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Planmeca Oy

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K230985Planmeca VisoDecember 28, 2023
K200572Planmeca RomexisDecember 2, 2020
K181576Planmeca VisoSeptember 13, 2018
K171385Planmeca RomexisNovember 14, 2017
K160506Planmeca ProMax 3D Max, Planmeca MaximityMay 20, 2016
K140713PLANMECA ROMEXISJune 16, 2014
K103689PLANMECA PROMAX 3D MIDMarch 17, 2011
K093590PLANMECA PROMAX 3D MAXMay 12, 2010
K091197PLANMECA PROSENSORJuly 29, 2009
K072244PLANMECA PROONESeptember 21, 2007
K060328PLANMECA PROMAX 3DMarch 15, 2006
K051464PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)June 24, 2005
K011619PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTATJune 29, 2001
K000771DIMAX 2May 3, 2000
K000428DIXI 2April 28, 2000
K000163PM 2002 PROLINE/AECApril 18, 2000
K000454DIMEX 2March 31, 2000
K984013PLANMECA INTRACAM STATIONJanuary 26, 1999
K980581PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEMApril 17, 1998
K970812PM 2002 CC PROLINEAugust 5, 1997