Orthopantomograph OP 3D 901085

GUDID 06430035873630

PaloDEx Group Oy

Limited-view-field CT system

• Primary Device ID: 06430035873630
• NIH Device Record Key: cc8ca86f-23fc-45f3-b977-d53d55a26cdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopantomograph OP 3D
• Version Model Number: 3D upgrade kit for OP 3D
• Catalog Number: 901085
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035873630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180947

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: 2021-06-08
• Device Publish Date: 2021-05-31

On-Brand Devices [Orthopantomograph OP 3D]

• 06430035872879: ORTHOPANTOMOGRAPH OP 3D (pan)
• 06430035872862: ORTHOPANTOMOGRAPH OP 3D cranio-maxillofacial xray device for panoramic, cephalometric and cbct i
• 06430035872688: ORTHOPANTOMOGRAPH OP 3D (pan/cbct)
• 06430035872886: ORTHOPANTOMOGRAPH OP 3D (pan/ceph)
• 06430035873630: 3D upgrade kit for OP 3D