ORTHOPANTOMOGRAPH OP 2D 901008

GUDID 06430035872701

PaloDEx Group Oy

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 06430035872701
• NIH Device Record Key: 221d1c7c-a3fb-47b4-bd47-6b1298b02957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOPANTOMOGRAPH OP 2D
• Version Model Number: OP30-2
• Catalog Number: 901008
• 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	06430035872701 [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: 2017-03-16

On-Brand Devices [ORTHOPANTOMOGRAPH OP 2D]

• 06430035872718: OP30-2
• 06430035872701: OP30-2