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Palodex Group Oy

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
10
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2413-2024Class IIOrthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces convenOctober 28, 2021
Z-0842-2020Class IIInstrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)January 7, 2020
Z-0839-2020Class IISoredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)January 7, 2020
Z-0841-2020Class IIKaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)January 7, 2020
Z-0840-2020Class IIGendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)January 7, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)September 12, 2024
K230505Orthopantomograph™ OP 3D LXJune 9, 2023
K180947Orthopantomograph OP 3DJune 7, 2018
K173646FS ErgoDecember 19, 2017
K163423Orthopantomograph OP300August 31, 2017
K162799CliniviewApril 25, 2017
K170813ORTHOPANTOMOGRAPH OP 3DApril 7, 2017
K133544OP300March 26, 2014
K130297SCANORA 3DXMay 29, 2013
K122018OP300December 10, 2012