GXDP-300 900714

GUDID 06430035872435

PaloDEx Group Oy

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 06430035872435
• NIH Device Record Key: cd17a68b-d2a2-4b99-951c-46b6cc2de096
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GXDP-300
• Version Model Number: GXDP-300
• Catalog Number: 900714
• 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

Customer Support Contacts

• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com
• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035872435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092591

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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