Intra Oral Sensor IOX1

GUDID 08809460309850

Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.

Dentium Co., Ltd

Dental digital imaging sensor, intraoral

• Primary Device ID: 08809460309850
• NIH Device Record Key: e3f25441-8298-4d9d-b5a3-0c05ed4f86c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intra Oral Sensor
• Version Model Number: IOX1
• Catalog Number: IOX1
• Company DUNS: 695504638
• Company Name: Dentium Co., Ltd
• 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: 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: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com
• Phone: +821064769603
• Email: yrna@dentium.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809460309850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201247

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2020-08-14
• Device Publish Date: 2020-08-06

On-Brand Devices [Intra Oral Sensor]

• 08809460309867: Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by det
• 08809460309850: Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by det