FDA Registration
Active
🇫🇮 Finland
PALODEX GROUP OY
Reg #: 3005383085
·
FEI: 3005383085
·
Expires 2026
Products
11
Proprietary Names
15
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- PALODEX GROUP OY
- Registration Number
- 3005383085
- FEI Number
- 3005383085
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NAHKELANTIE 160
- City
- Tuusula Uusimaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K180947
Owner / Operator
- Firm Name
- PaloDEx Group Oy
- Operator Number
- 9079085
- Address
- Nahkelantie 160, --
- City
- TUUSULA
- State
- Uusimaa
- Postal Code
- 04300
- Country
- FI
US Agent
- Business Name
- DENTAL IMAGING TECHNOLOGIES CORPORATION
- Contact Name
- Erika Martin
- Address
- 450 Commerce Drive
- City
- Quakertown
- State
- PA
- ZIP
- 18951
- Country
- US
- [email protected]
- Phone
- 980 3094441
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2018-06-29 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2014-04-07 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-03-23 |
| Analyzer, Medical Image | MYN | Class 2 | Radiology | No | 2026-03-09 |
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 2022-03-23 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2026-03-09 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2019-06-07 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2016-09-06 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2023-03-23 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2023-03-23 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2005-10-31 |
Proprietary Names
ORTHOPANTOMOGRAPH OP 3D
DIGORA Optime
DTX Studio Implant
DTX Studio Clinic
Imaging Plates for Imaging Plate Systems
DTX Studio Assist
Orthopantomograph OP 3D EX
Orthopantomograph OP 3D LX
IPS Casedesigner
Orthopantomograph OP 3D EX
Orthopantomograph OP 3D LX
DTX Studio Core
DTX Studio Lab
FOCUS
DTX Studio Diagnose
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device