ORTHOPANTOMOGRAPH™ OP 3D 901265-PTU

GUDID 06430035875092

ORTHOPANTOMOGRAPH™ OP 3D LX (PAN 3D)

PaloDEx Group Oy

Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system

• Primary Device ID: 06430035875092
• NIH Device Record Key: f99d4600-ec53-4167-9bcc-63849767728f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOPANTOMOGRAPH™ OP 3D
• Version Model Number: PCX-1
• Catalog Number: 901265-PTU
• Company DUNS: 459955188
• Company Name: PaloDEx Group Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	06430035875092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230505

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [ORTHOPANTOMOGRAPH™ OP 3D]

• 06430035875108: ORTHOPANTOMOGRAPH™ OP 3D LX (PAN, CEPH 3D)
• 06430035875092: ORTHOPANTOMOGRAPH™ OP 3D LX (PAN 3D)
• 06430035875139: OP 3D LX CEPH UPGRADE KIT