X PRO

GUDID 06430035872848

PaloDEx Group Oy

Dental CAD/CAM system, chairside

• Primary Device ID: 06430035872848
• NIH Device Record Key: f234cb24-988c-4fcb-9ca4-5c0c2aae56f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X PRO
• Version Model Number: IOS-1
• Company DUNS: 459955188
• Company Name: PaloDEx Group Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035872848 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-07
• Device Publish Date: 2019-10-30

Devices Manufactured by PaloDEx Group Oy

• 06430035872947 - OCCLUSAL 4C START-UP KIT: 2024-07-25 OCCLUSAL 4C START-UP KIT
• 06430035875177 - ORTHOPANTOMOGRAPH™ OP 3D: 2024-05-14 ORTHOPANTOMOGRAPH™ OP 3D EX (PAN 3D)
• 06430035875139 - ORTHOPANTOMOGRAPH™ OP 3D: 2024-03-22 OP 3D LX CEPH UPGRADE KIT
• 06430035875092 - ORTHOPANTOMOGRAPH™ OP 3D: 2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN 3D)
• 06430035875108 - ORTHOPANTOMOGRAPH™ OP 3D: 2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN, CEPH 3D)
• 06430035873630 - Orthopantomograph OP 3D: 2021-06-08
• 06430035874484 - OP 3D Carpus Holder: 2021-06-04 Carpus holder for Carpus imaging with Orthopantomograph OP 3D
• 06430035874354 - Bite blocks 10pcs OP 3D: 2021-06-03