Palodex Group Oy

FDA Filings

This page includes the latest FDA filings for Palodex Group Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005383085
FEI Number3005383085
NamePALODEX GROUP OY
Owner & OperatorPALODEX GROUP OY
Contact AddressNAHKELANTIE 160 --
TUUSULA FI-ES Etela-Suomen laani 04300 FI
Official Correspondent
  • TERHO - TURKUMAKI
  • 358-50-3209113-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNAHKELANTIE 160
TUUSULA, FINLAND Etela-Suomen laani, 04300 FI
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
PaloDEx Group Oy
ORTHOPANTOMOGRAPH™ OP 3D 901284-PTU2024-03-22
PaloDEx Group Oy
ORTHOPANTOMOGRAPH™ OP 3D 901266-PTU2023-10-10
PaloDEx Group Oy
ORTHOPANTOMOGRAPH™ OP 3D 901265-PTU2023-10-10
PaloDEx Group Oy
Orthopantomograph OP 3D 9010852021-06-08
PaloDEx Group Oy
OP 3D Carpus Holder 2021-06-04
PaloDEx Group Oy
BITE BLOCK (SET OF 10 PCS) 2021-06-03
PaloDEx Group Oy
CRANEX 3D PAN ACCESSORIES 2021-06-03
PaloDEx Group Oy
CRANEX 3D PAT POSIT ACCESSORIES 2021-06-03
PaloDEx Group Oy
Bite blocks 10pcs OP 3D 2021-06-03
PaloDEx Group Oy
Ear Holder Disposable Cover 2020-04-09
PaloDEx Group Oy
DISPOSABLE PLASTIC BAGS SIZE 0 DIGORA OPTIME 100 PCS 2020-03-09
PaloDEx Group Oy
PROTECTIVE BAG SIZE 3 100 PCS 2020-02-10
PaloDEx Group Oy
PROTECTIVE BAG SIZE 2 100 PCS 2020-02-10
PaloDEx Group Oy
PROTECTIVE BAG SIZE 1 100 PCS 2020-02-10
PaloDEx Group Oy
EAR ROD COVER DISPOSABLE CC3 2020-02-10
PaloDEx Group Oy
EAR HOLDER COVERS 2020-02-10
PaloDEx Group Oy
DISPOSABLE COVER ROLL 2020-02-10
PaloDEx Group Oy
LIP SUPPORT DISPOSABLE COVER 2020-02-10
PaloDEx Group Oy
BITE BLOCK DISPOSABLE COVER ROLL 2020-02-10
PaloDEx Group Oy
Temple Support Disposable Cover 2020-02-10
PaloDEx Group Oy
Nasion Support Disposable Cover 2020-02-10
PaloDEx Group Oy
Lip Support Disposable Cover 2020-02-10
PaloDEx Group Oy
Bite Block Disposable Cover 2020-02-10
PaloDEx Group Oy
Chin Support Disposable Cover 2020-02-10
PaloDEx Group Oy
Hygiene bag Occlusal 4C 100 PCS 2020-02-10
PaloDEx Group Oy
Comfort Occlusal Hygiene Bags for occlusal projection images, size 4C, 100 PCS 2020-02-10
PaloDEx Group Oy
DIGORA BAG SIZE 3 200 PCS 2020-02-10
PaloDEx Group Oy
DIGORA BAG SIZE 2 200 PCS 2020-02-10
PaloDEx Group Oy
DIGORA BAG SIZE 1 200 PCS 2020-02-10
PaloDEx Group Oy
DIGORA BAG SIZE 0 200 PCS 2020-02-10
PaloDEx Group Oy
CLASSIC BAG SIZE 3 200 PCS 2020-02-10
PaloDEx Group Oy
CLASSIC BAG SIZE 2 200 PCS 2020-02-10
PaloDEx Group Oy
CLASSIC BAG SIZE 1 200 PCS 2020-02-10
PaloDEx Group Oy
CLASSIC BAG SIZE 0 200 PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag for Imaging Plate Systems SIZE 3 200 PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag for Imaging Plate Systems SIZE 2 200 PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag for Imaging Plate Systems SIZE 1 200 PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag for Imaging Plate Systems SIZE 0 200 PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag FL for Imaging Plate Systems SIZE 3 200 PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag FL for Imaging Plate Systems SIZE 2 200 PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag FL for Imaging Plate Systems SIZE 1 200PCS 2020-02-10
PaloDEx Group Oy
Hygiene bag FL for Imaging Plate Systems SIZE 0 200 PCS 2020-02-10
PaloDEx Group Oy
OPTIBAG SIZE 3 200PCS 2020-02-10
PaloDEx Group Oy
OPTIBAG SIZE 2 200PCS 2020-02-10
PaloDEx Group Oy
OPTIBAG SIZE 1 200PCS 2020-02-10
PaloDEx Group Oy
OPTIBAG SIZE 0 200PCS 2020-02-10
PaloDEx Group Oy
FS Ergo 9010392020-01-27
PaloDEx Group Oy
KAVO X PRO REUSABLE TIP SUPPORT 2019-11-07
PaloDEx Group Oy
KAVO X PRO USB INTERFACE BOX 2019-11-07
PaloDEx Group Oy
X PRO DISPOSABLE TIP 2019-11-07
PaloDEx Group Oy
X PRO 2019-11-07
PALODEX GROUP OY
X Pro2019-06-07
PALODEX GROUP OY
KaVo X Pro USB Interface Box2019-06-07
PALODEX GROUP OY
KaVo X Pro Reusable Tip Support2019-06-07
PALODEX GROUP OY
KaVo X Pro Disposable Tips2019-06-07
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D 9009902019-05-20
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D 9009892019-02-26
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D 9009922019-02-26
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D 9009912019-02-26
PaloDEx Group Oy
Scan eXam 9004672018-08-23
PaloDEx Group Oy
GXPS-500 9004692018-08-23
PaloDEx Group Oy
DIGORA Optime 9006822018-08-23
PaloDEx Group Oy
DIGORA Optime 9002672018-08-23
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D Pro 9010062018-07-06
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D Pro 9010052018-07-06
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D Pro 9010042018-07-06
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D Pro 9010032018-07-06
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D Pro 9010022018-07-06
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D Pro 9010012018-07-06
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 2D 9010082018-07-06
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 2D 9010082018-07-06
PaloDEx Group Oy
Focus 9009862018-07-06
PaloDEx Group Oy
Snapshot 9001672018-07-06
PaloDEx Group Oy
Snapshot 9001662018-07-06
PaloDEx Group Oy
Minray 762112018-07-06
PaloDEx Group Oy
Focus 506002018-07-06
PaloDEx Group Oy
Pan eXam 9006542018-07-06
PaloDEx Group Oy
GXDP-300 9007142018-07-06
PaloDEx Group Oy
Cranex Novus e 9006512018-07-06
PaloDEx Group Oy
OP30 9006532018-07-06
PaloDEx Group Oy
Cranex D Ceph 40000004-SDX2018-07-06
PaloDEx Group Oy
Cranex D 40000003-SDX2018-07-06
PaloDEx Group Oy
OC200D 2004672018-07-06
PaloDEx Group Oy
OP200D 51555072018-07-06
PaloDEx Group Oy
Scanora 6 2132482018-07-06
PaloDEx Group Oy
Cliniview 11 2131832018-07-06
PaloDEx Group Oy
Orthopanthomorgraph OP300 9004302018-07-06
PaloDEx Group Oy
Orthopanthomorgraph OP300 9004312018-07-06
PaloDEx Group Oy
Orthopanthomorgraph OP300 9004332018-07-06
PaloDEx Group Oy
Orthopanthomorgraph OP300 9004342018-07-06
PaloDEx Group Oy
Orthopanthomorgraph OP300 9004352018-07-06
PaloDEx Group Oy
Orthopanthomorgraph OP300 9005292018-07-06
PaloDEx Group Oy
CRANEX 3D 9005302018-07-06
PaloDEx Group Oy
CRANEX 3D 9005312018-07-06
PaloDEx Group Oy
CRANEX 3D 9005322018-07-06
PaloDEx Group Oy
CRANEX 3D 9005332018-07-06
PaloDEx Group Oy
CRANEX 3D 9005342018-07-06
PaloDEx Group Oy
CRANEX 3D 9005352018-07-06
PaloDEx Group Oy
GXDP-700 9005642018-07-06
PaloDEx Group Oy
GXDP-700 9005652018-07-06
PaloDEx Group Oy
GXDP-700 9005662018-07-06
PaloDEx Group Oy
GXDP-700 9005672018-07-06
PaloDEx Group Oy
CRANEX 3D 9007962018-07-06
PALODEX GROUP OY
ORTHOPANTOMOGRAPH OP 3D2018-06-29
PaloDEx Group Oy
Orthopantomograph OP 3D2018-06-07
PaloDEx Group Oy
FS Ergo2017-12-19
PALODEX GROUP OY
ORTHOPANTOMOGRAPH OP3002017-09-11
PALODEX GROUP OY
ORTHOPANTOMOGRAPH OP 3D Pro2017-09-11
PaloDEx Group Oy
Orthopantomograph OP3002017-08-31
PALODEX GROUP OY
SCANORA?2017-05-02
PALODEX GROUP OY
CLINIVIEW?2017-05-02
Palodex Group Oy
Cliniview2017-04-25
PALODEX GROUP OY
ORTHOPANTOMOGRAPH? OP 3D2017-04-20
PaloDEx Group Oy
ORTHOPANTOMOGRAPH OP 3D2017-04-07
PALODEX GROUP OY
SCANORA Mobile2017-02-03
PALODEX GROUP OY
CLINIVIEW Mobile2017-02-03
PALODEX GROUP OY
ORTHOPANTOMOGRAPH? OP3002014-04-25
PALODEX GROUP OY
ORTHOPANTOMOGRAPH? OP 3D Pro2014-04-25
PALODEX GROUP OY
Cranex 3Dx2014-04-25
PALODEX GROUP OY
DIGORA Optime2014-04-07
PALODEX GROUP OY
OP3002014-03-26
PALODEX GROUP OY
Pan eXam plus2013-08-16
PALODEX GROUP OY
OP3002013-08-16
PALODEX GROUP OY
GXDP-7002013-08-16
PALODEX GROUP OY
CRANEX 3D2013-08-16
PALODEX GROUP OY
SCANORA 3DX2013-05-29
PALODEX GROUP OY
OP3002012-12-10
PALODEX GROUP OY
Pan eXam Plus2010-12-20
PALODEX GROUP OY
OP3002010-12-20
PALODEX GROUP OY
GXDP-7002010-12-20
PALODEX GROUP OY
CRANEX 3D2010-12-20
PALODEX GROUP OY
Pan eXam2010-04-15
PALODEX GROUP OY
ORTHOPANTOMOGRAPH? OP302010-04-15
PALODEX GROUP OY
ORTHOPANTOMOGRAPH? OP 2D2010-04-15
PALODEX GROUP OY
GXDP-3002010-04-15
PALODEX GROUP OY
Cranex Novus e2010-04-15
PALODEX GROUP OY
Snapshot2008-09-17
PALODEX GROUP OY
DIGORA for Windows2007-12-04
PALODEX GROUP OY
Scan eXam2007-12-04
PALODEX GROUP OY
GXPS-5002007-12-04
PALODEX GROUP OY
DIGORA Optime2007-12-04
PALODEX GROUP OY
Scan eXam2007-12-04
PALODEX GROUP OY
GXPS-5002007-12-04
PALODEX GROUP OY
DIGORA Optime2007-12-04
PALODEX GROUP OY
Scan eXam2007-12-04
PALODEX GROUP OY
GXPS-5002007-12-04
PALODEX GROUP OY
DIGORA Optime2007-12-04
PALODEX GROUP OY
VOLUMETRIC TOMOGRAPHY2007-02-27
PALODEX GROUP OY
VOLUMETRIC TOMOGRAPHY2007-02-27
PALODEX GROUP OY
OP200D2005-10-31
PALODEX GROUP OY
OP2002005-10-31
PALODEX GROUP OY
OC200D2005-10-31
PALODEX GROUP OY
OC2002005-10-31
PALODEX GROUP OY
Modification to Focus2005-10-31
PALODEX GROUP OY
FOCUS2005-10-31

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020081922866Anvers,Belgium -> Philadelphia, PennsylvaniaDENTAL EQUIPMENT19 PKG
2020081527443Anvers,Belgium -> Philadelphia, PennsylvaniaDENTAL EQUIPMENT19 PKG
2020081335504Anvers,Belgium -> Philadelphia, PennsylvaniaDENTAL EQUIPMENT19 PKG
2020042417926Anvers,Belgium -> Philadelphia, PennsylvaniaDENTAL EQUIPMENT70 PKG
2020042417926Anvers,Belgium -> Philadelphia, PennsylvaniaDENTAL EQUIPMENT70 PKG
2020041825340Anvers,Belgium -> Philadelphia, PennsylvaniaDENTAL EQUIPMENT28 PKG
2020040918371Anvers,Belgium -> Philadelphia, PennsylvaniaDENTAL EQUIPMENT45 PKG
202003304698Rotterdam,Netherlands -> Charleston, South CarolinaDENTAL EQUIPMENT82 PKG
202003304698Rotterdam,Netherlands -> Charleston, South CarolinaDENTAL EQUIPMENT82 PKG
202003304698Rotterdam,Netherlands -> Charleston, South CarolinaDENTAL EQUIPMENT82 PKG
202003196825Rotterdam,Netherlands -> Charleston, South CarolinaDENTAL EQUIPMENT90 PKG
202003196825Rotterdam,Netherlands -> Charleston, South CarolinaDENTAL EQUIPMENT90 PKG
202003196825Rotterdam,Netherlands -> Charleston, South CarolinaDENTAL EQUIPMENT90 PKG

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