Planmeca Oy
FDA 510(k) & PMA Approved Devices — 27 products
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Total Devices27
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K230985 | Planmeca Viso | OAS | 2023-12-28 | View |
| 510(k) | K200572 | Planmeca Romexis | LLZ | 2020-12-02 | View |
| 510(k) | K181576 | Planmeca Viso | OAS | 2018-09-13 | View |
| 510(k) | K171385 | Planmeca Romexis | LLZ | 2017-11-14 | View |
| 510(k) | K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | OAS | 2016-05-20 | View |
| 510(k) | K103689 | PLANMECA PROMAX 3D MID | MUH | 2011-03-17 | View |
| 510(k) | K093590 | PLANMECA PROMAX 3D MAX | MUH | 2010-05-12 | View |
| 510(k) | K091197 | PLANMECA PROSENSOR | EHD | 2009-07-29 | View |
| 510(k) | K072244 | PLANMECA PROONE | MUH | 2007-09-21 | View |
| 510(k) | K060328 | PLANMECA PROMAX 3D | MUH | 2006-03-15 | View |
| 510(k) | K051464 | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) | EHD | 2005-06-24 | View |
| 510(k) | K011619 | PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT | EHD | 2001-06-29 | View |
| 510(k) | K000771 | DIMAX 2 | EHD | 2000-05-03 | View |
| 510(k) | K000428 | DIXI 2 | EHD | 2000-04-28 | View |
| 510(k) | K000163 | PM 2002 PROLINE/AEC | EHD | 2000-04-18 | View |
| 510(k) | K000454 | DIMEX 2 | MUH | 2000-03-31 | View |
| 510(k) | K984013 | PLANMECA INTRACAM STATION | EIA | 1999-01-26 | View |
| 510(k) | K980581 | PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM | EHD | 1998-04-17 | View |
| 510(k) | K970812 | PM 2002 CC PROLINE | EHD | 1997-08-05 | View |
| 510(k) | K972033 | PLANMECA INTRACAM | EIA | 1997-06-20 | View |
No matching devices.
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