HSA · registration DE0019416PaloDEx ORTHOPANTOMOGRAPH™ OP 3D Digital Imaging System
- Registration number
- DE0019416
- Model name
- Chin Support Disposable Cover; Bite Block Disposable Cover; Nasion Support Disposable Cover; Ear Holder Covers; ORTHOPANTOMOGRAPH™ OP 3D Pan; ORTHOPANTOMOGRAPH™ OP 3D PanCeph; ORTHOPANTOMOGRAPH™ OP 3D Pan 3D; ORTHOPANTOMOGRAPH™ OP 3D PanCeph3D; Lip Support Disposable Cover; OP 3D 9X14 FOV UPGRADE; CEPH UPGRADE KIT FOR OP 3D; 3D UPPGRADE KIT FOR OP 3D; OP 3D Collimator; OP 3D Tubehead; OP 3D Sensor
- Model identifier
- 900509; 900510; 900511; 900638 (208224); 900989; 900990; 900991; 900992; 901011; 901012; 901084; 901085; SP01217; SP01243; SP01297
- Registration date
- July 17, 2017
- Source update date
- May 20, 2025
- Risk class
- Class C
- Product owner
- PaloDEx Group Oy
- Registrant / registration holder
- EHC SUPPLY
PaloDEx ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric, or 3D images of the cranio-maxillofacial complex for use in diagnostic support. The device can also be configured to take carpus images. PaloDEx ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.
- Product owner address
- Nahkelantie 160, 04300 Tuusula, Finland
- Registrant address
- 13 STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.