Acteon

GUDID 08052870660916

DENTAL XRAY COMPANY SRL

Dental digital imaging sensor, intraoral

• Primary Device ID: 08052870660916
• NIH Device Record Key: a7effc3e-fd32-4cdf-9fc6-c40537be8376
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acteon
• Version Model Number: Sopix 3 HD
• Company DUNS: 439922846
• Company Name: DENTAL XRAY COMPANY 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052870660916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133271

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: 2019-07-09
• Device Publish Date: 2019-07-01

On-Brand Devices [Acteon]

• 08052870661418: X-MIND evo
• 08052870661210: X-MIND evo D
• 08052870661012: X-MIND evo 3D
• 08052870660916: Sopix 3 HD
• 08052870660817: Sopix 3
• 08052870660022: X-MIND prime 3D
• 08052870660015: X-MIND prime