Iris IRIS-X90

GUDID 00813557020205

IRIS X90 Intraoral Camera

Digital Doc LLC

Intraoral camera

• Primary Device ID: 00813557020205
• NIH Device Record Key: b3746318-7cfe-4074-8b69-5a9c98d45a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iris
• Version Model Number: X90
• Catalog Number: IRIS-X90
• Company DUNS: 036787190
• Company Name: Digital Doc LLC
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813557020205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981663

FDA Product Code

• EIA: Unit, Operative Dental

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: 2025-01-29
• Device Publish Date: 2025-01-21

On-Brand Devices [Iris]

• 00813557020205: IRIS X90 Intraoral Camera
• 00813557020144: IRIS X80 Intraoral Camera
• 00813557020007: IRIS USB 2.0 Intraoral Camera