510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Planmeca Oy

Helsinki Uusimaa, FI

Planmeca Oy appears in FDA device records in Helsinki Uusimaa, FI. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
28
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 28 510(k) clearances for Planmeca Oy between 1993 and 2023. The busiest year on record is 1997, with 4. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Planmeca Oy, by decision year
YearClearances
19931
19952
19962
19974
19981
19991
20004
20011
20051
20061
20071
20091
20101
20111
20141
20161
20171
20181
20201
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K230985Planmeca VisoOASSubstantially Equivalent
K200572Planmeca RomexisLLZSubstantially Equivalent
K181576Planmeca VisoOASSubstantially Equivalent
K171385Planmeca RomexisLLZSubstantially Equivalent
K160506Planmeca ProMax 3D Max, Planmeca MaximityOASSubstantially Equivalent
K140713PLANMECA ROMEXISLLZSubstantially Equivalent
K103689PLANMECA PROMAX 3D MIDMUHSubstantially Equivalent
K093590PLANMECA PROMAX 3D MAXMUHSubstantially Equivalent
K091197PLANMECA PROSENSOREHDSubstantially Equivalent
K072244PLANMECA PROONEMUHSubstantially Equivalent
K060328PLANMECA PROMAX 3DMUHSubstantially Equivalent
K051464PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)EHDSubstantially Equivalent
K011619PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTATEHDSubstantially Equivalent
K000771DIMAX 2EHDSubstantially Equivalent
K000428DIXI 2EHDSubstantially Equivalent
K000163PM 2002 PROLINE/AECEHDSubstantially Equivalent
K000454DIMEX 2MUHSubstantially Equivalent
K984013PLANMECA INTRACAM STATIONEIASubstantially Equivalent
K980581PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEMEHDSubstantially Equivalent
K970812PM 2002 CC PROLINEEHDSubstantially Equivalent
K972033PLANMECA INTRACAMEIASubstantially Equivalent
K970975PROSTYLE INTRAEHDSubstantially Equivalent
K970263PM 2002 CC PROLINEEHDSubstantially Equivalent
K963209PROSTYLE COMPACTKLCSubstantially Equivalent
K961420PROSTYLE COMPACTEIASubstantially Equivalent
K955429PROSTYLE INTRAEHDSubstantially Equivalent
K952763PANORAMIC X-RAY UNIT (MODIFICATION)EHDSubstantially Equivalent
K934063PANORAMIC X-RAY UNITS, MODIFICATIONEHDSubstantially Equivalent

Registered establishments

FDA registered establishments for Planmeca Oy, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80308761000207287Planmeca OyAsentajankatu 6, Helsinki Uusimaa 00880 FI2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain