Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Planmeca Oy — Predicate Candidate Screening

28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time
187 days90th percentile
28clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230985Planmeca VisoPlanmeca Oy2023-12-282660
K200572Planmeca RomexisPlanmeca Oy2020-12-022720
K181576Planmeca VisoPlanmeca Oy2018-09-13900
K171385Planmeca RomexisPlanmeca Oy2017-11-141870
K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy2016-05-20860
K140713PLANMECA ROMEXISPlanmeca Oy2014-06-16870
K103689PLANMECA PROMAX 3D MIDPlanmeca Oy2011-03-17900
K093590PLANMECA PROMAX 3D MAXPlanmeca Oy2010-05-121740
K091197PLANMECA PROSENSORPlanmeca Oy2009-07-29970
K072244PLANMECA PROONEPlanmeca Oy2007-09-21390
K060328PLANMECA PROMAX 3DPlanmeca Oy2006-03-15340
K051464PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)Planmeca Oy2005-06-24210
K011619PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTATPlanmeca Oy2001-06-29350
K000771DIMAX 2Planmeca Oy2000-05-03550
K000428DIXI 2Planmeca Oy2000-04-28790
K000163PM 2002 PROLINE/AECPlanmeca Oy2000-04-18900
K000454DIMEX 2Planmeca Oy2000-03-31490
K984013PLANMECA INTRACAM STATIONPlanmeca Oy1999-01-26760
K980581PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEMPlanmeca Oy1998-04-17590
K970812PM 2002 CC PROLINEPlanmeca Oy1997-08-051530
K972033PLANMECA INTRACAMPlanmeca Oy1997-06-20180
K970975PROSTYLE INTRAPlanmeca Oy1997-04-01150
K970263PM 2002 CC PROLINEPlanmeca Oy1997-02-26340
K963209PROSTYLE COMPACTPlanmeca Oy1996-10-24690
K961420PROSTYLE COMPACTPlanmeca Oy1996-09-101510
K955429PROSTYLE INTRAPlanmeca Oy1995-12-11130
K952763PANORAMIC X-RAY UNIT (MODIFICATION)Planmeca Oy1995-10-071350
K934063PANORAMIC X-RAY UNITS, MODIFICATIONPlanmeca Oy1993-12-151060

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda