StarX-1

GUDID E31593800001000

FONA SRL

Dental digital imaging sensor, intraoral

• Primary Device ID: E31593800001000
• NIH Device Record Key: 9eaed289-9769-4ee0-bdc5-7ab2b14738b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarX-1
• Version Model Number: 9380000100
• Company DUNS: 514320345
• Company Name: FONA SRL
• 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
HIBCC	E31593800001000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212103

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: 2021-09-10
• Device Publish Date: 2021-09-02

Devices Manufactured by FONA SRL

• E3158468260320 - FONA ART Plus: 2023-06-20
• E3158468463121 - FONA ART Plus C: 2023-06-20
• E3158468463221 - FONA ART Plus C: 2023-06-20
• E3159319001700 - FONA XDC: 2022-09-14
• E3158468600000 - Stellaris 3D: 2022-05-09
• E3158468600002 - Stellaris 3D Ceph: 2022-05-09
• E3158468600007 - Stellaris 2D: 2022-05-09
• E3158468600008 - Stellaris 2D Ceph: 2022-05-09