Medical Device Manufacturer · FI , Helsinki

Planmeca Oy

28 submissions · 28 cleared · Since 1993
28
Total
28
Cleared
0
Denied

Planmeca Oy — FDA 510(k) Submissions

Planmeca Oy has submitted 28 FDA 510(k) premarket notifications since 1993, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, X-ray, Extraoral With Timer, System, X-ray, Extraoral Source, Digital, System, Image Processing, Radiological, X-ray, Tomography, Computed, Dental, Unit, Operative Dental . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
Planmeca Viso
K230985 · OAS X-ray, Tomography,... · Radiology
Dec 2023 266d
Planmeca Romexis
K200572 · LLZ System, Image Processing,... · Radiology
Dec 2020 272d
Planmeca Viso
K181576 · OAS X-ray, Tomography,... · Radiology
Sep 2018 90d
Planmeca Romexis
K171385 · LLZ System, Image Processing,... · Radiology
Nov 2017 187d
Planmeca ProMax 3D Max, Planmeca Maximity
K160506 · OAS X-ray, Tomography,... · Radiology
May 2016 86d
PLANMECA ROMEXIS
K140713 · LLZ System, Image Processing,... · Radiology
Jun 2014 87d
PLANMECA PROMAX 3D MID
K103689 · MUH System, X-ray, Extraoral... · Radiology
Mar 2011 90d
PLANMECA PROMAX 3D MAX
K093590 · MUH System, X-ray, Extraoral... · Radiology
May 2010 174d
PLANMECA PROSENSOR
K091197 · EHD Unit, X-ray, Extraoral... · Radiology
Jul 2009 97d
PLANMECA PROONE
K072244 · MUH System, X-ray, Extraoral... · Radiology
Sep 2007 39d
PLANMECA PROMAX 3D
K060328 · MUH System, X-ray, Extraoral... · Radiology
Mar 2006 34d
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
K051464 · EHD Unit, X-ray, Extraoral... · Radiology
Jun 2005 21d
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · EHD Unit, X-ray, Extraoral... · Radiology
Jun 2001 35d
DIMAX 2
K000771 · EHD Unit, X-ray, Extraoral... · Radiology
May 2000 55d
DIXI 2
K000428 · EHD Unit, X-ray, Extraoral... · Radiology
Apr 2000 79d
PM 2002 PROLINE/AEC
K000163 · EHD Unit, X-ray, Extraoral... · Radiology
Apr 2000 90d
DIMEX 2
K000454 · MUH System, X-ray, Extraoral... · Radiology
Mar 2000 49d
PLANMECA INTRACAM STATION
K984013 · EIA Unit, Operative Dental · Dental
Jan 1999 76d
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
K980581 · EHD Unit, X-ray, Extraoral... · Radiology
Apr 1998 59d
PM 2002 CC PROLINE
K970812 · EHD Unit, X-ray, Extraoral... · Radiology
Aug 1997 153d
PLANMECA INTRACAM
K972033 · EIA Unit, Operative Dental · Dental
Jun 1997 18d
PROSTYLE INTRA
K970975 · EHD Unit, X-ray, Extraoral... · Radiology
Apr 1997 15d
PM 2002 CC PROLINE
K970263 · EHD Unit, X-ray, Extraoral... · Radiology
Feb 1997 34d
PROSTYLE COMPACT
K963209 · KLC Chair, Dental, With... · Dental
Oct 1996 69d
PROSTYLE COMPACT
K961420 · EIA Unit, Operative Dental · Dental
Sep 1996 151d
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