Clio Prime

GUDID 00851159007101

SOTA PRECISION OPTICS, INC.

Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital

• Primary Device ID: 00851159007101
• NIH Device Record Key: 5e93b7f4-e9c5-4c0f-ba7f-759af03aa72c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clio Prime
• Version Model Number: Pedo
• Company DUNS: 601005523
• Company Name: SOTA PRECISION OPTICS, INC.
• 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

Customer Support Contacts

• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com
• Phone: 714-532-6100
• Email: info@sotaimaging.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851159007101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202664

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-29
• Device Publish Date: 2021-01-21

On-Brand Devices [Clio Prime]

• 00851159007118: Prime
• 00851159007101: Pedo