FDA 510(k) Applications Submitted by Planmeca Oy

FDA 510(k) Number Submission Date Device Name Applicant
K000454 02/11/2000 DIMEX 2 PLANMECA OY
K000771 03/09/2000 DIMAX 2 PLANMECA OY
K091197 04/23/2009 PLANMECA PROSENSOR PLANMECA OY
K011619 05/25/2001 PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT PLANMECA OY
K051464 06/03/2005 PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) PLANMECA OY
K000163 01/19/2000 PM 2002 PROLINE/AEC PLANMECA OY
K970263 01/23/1997 PM 2002 CC PROLINE PLANMECA OY
K000428 02/09/2000 DIXI 2 PLANMECA OY
K060328 02/09/2006 PLANMECA PROMAX 3D PLANMECA OY
K980581 02/17/1998 PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM PLANMECA OY
K160506 02/24/2016 Planmeca ProMax 3D Max, Planmeca Maximity PLANMECA OY
K970812 03/05/1997 PM 2002 CC PROLINE PLANMECA OY
K200572 03/05/2020 Planmeca Romexis Planmeca Oy
K970975 03/17/1997 PROSTYLE INTRA PLANMECA OY
K140713 03/21/2014 PLANMECA ROMEXIS PLANMECA OY
K961420 04/12/1996 PROSTYLE COMPACT PLANMECA OY
K171385 05/11/2017 Planmeca Romexis Planmeca Oy
K972033 06/02/1997 PLANMECA INTRACAM PLANMECA OY
K181576 06/15/2018 Planmeca Viso Planmeca Oy
K072244 08/13/2007 PLANMECA PROONE PLANMECA OY
K963209 08/16/1996 PROSTYLE COMPACT PLANMECA OY
K984013 11/11/1998 PLANMECA INTRACAM STATION PLANMECA OY
K093590 11/19/2009 PLANMECA PROMAX 3D MAX PLANMECA OY
K103689 12/17/2010 PLANMECA PROMAX 3D MID PLANMECA OY


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