Company ยท FI
Planmeca Oy
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2023. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 14 |
| EIA | Unit, Operative Dental | 6 |
| MUH | System, X-Ray, Extraoral Source, Digital | 5 |
| KLC | Chair, Dental, With Operative Unit | 3 |
| LLZ | System, Image Processing, Radiological | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 |
| BZG | Spirometer, Diagnostic | 1 |
| EAZ | Light, Operating, Dental | 1 |
| EBA | Light, Surgical Headlight | 1 |
| IZH | System, X-Ray, Mammographic | 1 |
| JAC | System, X-Ray, Film Marking, Radiographic | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 28, 2023 | K230985 | Planmeca Viso Planmeca Oy, FI | OAS |
| Dec 2, 2020 | K200572 | Planmeca Romexis Planmeca Oy, FI | LLZ |
| Sep 13, 2018 | K181576 | Planmeca Viso Planmeca Oy, FI | OAS |
| Nov 14, 2017 | K171385 | Planmeca Romexis Planmeca Oy, FI | LLZ |
| May 20, 2016 | K160506 | Planmeca ProMax 3D Max, Planmeca Maximity Planmeca Oy, FI | OAS |
| Jun 16, 2014 | K140713 | PLANMECA ROMEXIS Planmeca Oy, FI | LLZ |
| Sep 23, 2011 | K111361 | PLANMED NUANCE EXCEL Planmeca USA, Inc. | MUE |
| Mar 17, 2011 | K103689 | PLANMECA PROMAX 3D MID Planmeca Oy, FI | MUH |
| May 12, 2010 | K093590 | PLANMECA PROMAX 3D MAX Planmeca Oy, FI | MUH |
| Jul 29, 2009 | K091197 | PLANMECA PROSENSOR Planmeca Oy | EHD |
| Aug 29, 2008 | K081699 | PLANMECA SOVEREIGN Planmeca USA, Inc. | EIA |
| Sep 21, 2007 | K072244 | PLANMECA PROONE Planmeca Oy, FI | MUH |
| Mar 15, 2006 | K060328 | PLANMECA PROMAX 3D Planmeca Oy, FI | MUH |
| Jun 24, 2005 | K051464 | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) Planmeca Oy | EHD |
| Jun 29, 2001 | K011619 | PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT Planmeca Oy | EHD |
| May 3, 2000 | K000771 | DIMAX 2 Planmeca Oy | EHD |
| Apr 28, 2000 | K000428 | DIXI 2 Planmeca Oy, FI | EHD |
| Apr 18, 2000 | K000163 | PM 2002 PROLINE/AEC Planmeca Oy, FI | EHD |
| Mar 31, 2000 | K000454 | DIMEX 2 Planmeca Oy | MUH |
| Jan 26, 1999 | K984013 | PLANMECA INTRACAM STATION Planmeca Oy, FI | EIA |
| Apr 17, 1998 | K980581 | PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM Planmeca Oy, FI | EHD |
| Aug 5, 1997 | K970812 | PM 2002 CC PROLINE Planmeca Oy, FI | EHD |
| Jun 20, 1997 | K972033 | PLANMECA INTRACAM Planmeca Oy, FI | EIA |
| Apr 1, 1997 | K970975 | PROSTYLE INTRA Planmeca Oy, FI | EHD |
| Feb 26, 1997 | K970263 | PM 2002 CC PROLINE Planmeca Oy, FI | EHD |
| Oct 24, 1996 | K963209 | PROSTYLE COMPACT Planmeca Oy, FI | KLC |
| Sep 10, 1996 | K961420 | PROSTYLE COMPACT Planmeca Oy, FI | EIA |
| Dec 11, 1995 | K955429 | PROSTYLE INTRA Planmeca Oy, FI | EHD |
| Oct 7, 1995 | K952763 | PANORAMIC X-RAY UNIT (MODIFICATION) Planmeca Oy, FI | EHD |
| Jan 31, 1994 | K923534 | PM2002 PROLINE Planmeca USA, Inc., FI | KLC |
| Dec 15, 1993 | K934063 | PANORAMIC X-RAY UNITS, MODIFICATION Planmeca Oy, FI | EHD |
| Mar 4, 1993 | K923533 | ADMARK Planmeca USA, Inc., FI | JAC |
| Dec 21, 1992 | K923462 | DELIGHT Planmeca USA, Inc., FI | EAZ |
| Dec 21, 1992 | K923461 | PM2002 PROLINE, PM2002 PROLINE EC Planmeca USA, Inc., FI | KLC |
| Apr 18, 1991 | K904953 | PLANMED SOPHIE Planmeca USA, Inc., FI | IZH |
| Jan 30, 1991 | K904948 | PM2002 CC AND PM2002 EC Planmeca USA, Inc., FI | EIA |
| Jan 30, 1991 | K904947 | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE Planmeca USA, Inc., FI | BZG |
| Nov 26, 1986 | K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC Planmeca USA, Inc. | EHD |
| Sep 19, 1984 | K842359 | AUTOMATIC PATIENT CHAIR PM2000 & A Planmeca USA, Inc. | |
| Sep 12, 1984 | K842357 | PM 2000 DENTAL UNIT Planmeca USA, Inc. | EIA |
| Jul 31, 1984 | K842358 | ISOLIGHT Planmeca USA, Inc. | EBA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||