ITA.O IT17-001R

GUDID 08052675320084

ITA.O ITALIAN ORTHODONTIC SYSTEM SRL

Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear Orthodontic extraoral headgear

• Primary Device ID: 08052675320084
• NIH Device Record Key: 23d322d7-e715-4407-b9d1-e97d3197ec71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITA.O
• Version Model Number: Maschera facciale MAXI Rosso
• Catalog Number: IT17-001R
• Company DUNS: 513891569
• Company Name: ITA.O ITALIAN ORTHODONTIC SYSTEM 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052675320084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202855

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

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: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [ITA.O]

• 08052675320091: Maschera facciale MAXI Verde
• 08052675320084: Maschera facciale MAXI Rosso
• 08052675320077: Maschera facciale MAXI Giallo
• 08052675320060: Maschera facciale MAXI Blu
• 08052675320053: Maschera facciale MAXI Bianco
• 08052675320046: Maschera facciale MINI Verde
• 08052675320039: Maschera facciale MINI Rosso
• 08052675320022: Maschera facciale MINI Giallo
• 08052675320015: Maschera facciale MINI Blu
• 08052675320008: Maschera facciale MINI Bianco