Planmeca Oy - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
FDA 510(k) cleared devices by Planmeca Oy Radiology ✕
24 devices
Cleared
Dec 28, 2023
Planmeca Viso
Radiology
266d
Cleared
Dec 02, 2020
Planmeca Romexis
Radiology
272d
Cleared
Sep 13, 2018
Planmeca Viso
Radiology
90d
Cleared
Nov 14, 2017
Planmeca Romexis
Radiology
187d
Cleared
May 20, 2016
Planmeca ProMax 3D Max, Planmeca Maximity
Radiology
86d
Cleared
Jun 16, 2014
PLANMECA ROMEXIS
Radiology
87d
Cleared
Mar 17, 2011
PLANMECA PROMAX 3D MID
Radiology
90d
Cleared
May 12, 2010
PLANMECA PROMAX 3D MAX
Radiology
174d
Cleared
Jul 29, 2009
PLANMECA PROSENSOR
Radiology
97d
Cleared
Sep 21, 2007
PLANMECA PROONE
Radiology
39d
Cleared
Mar 15, 2006
PLANMECA PROMAX 3D
Radiology
34d
Cleared
Jun 24, 2005
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
Radiology
21d
Cleared
Jun 29, 2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
Radiology
35d
Cleared
May 03, 2000
DIMAX 2
Radiology
55d
Cleared
Apr 28, 2000
DIXI 2
Radiology
79d
Cleared
Apr 18, 2000
PM 2002 PROLINE/AEC
Radiology
90d
Cleared
Mar 31, 2000
DIMEX 2
Radiology
49d
Cleared
Apr 17, 1998
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
Radiology
59d
Cleared
Aug 05, 1997
PM 2002 CC PROLINE
Radiology
153d
Cleared
Apr 01, 1997
PROSTYLE INTRA
Radiology
15d
Cleared
Feb 26, 1997
PM 2002 CC PROLINE
Radiology
34d
Cleared
Dec 11, 1995
PROSTYLE INTRA
Radiology
13d
Cleared
Oct 07, 1995
PANORAMIC X-RAY UNIT (MODIFICATION)
Radiology
135d
Cleared
Dec 15, 1993
PANORAMIC X-RAY UNITS, MODIFICATION
Radiology
106d