DC-Air™ Intraoral Sensor

GUDID 64298105870606

DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.

Athlos Oy

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• Primary Device ID: 64298105870606
• NIH Device Record Key: 5a53ab25-a405-47c2-b4c8-856cb8b095bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-Air™ Intraoral Sensor
• Version Model Number: WIOS-S2
• Company DUNS: 368444471
• Company Name: Athlos Oy
• 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	64298105870088 [Primary]
GS1	64298105870606 [Package]; Contains: 64298105870088; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211688

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: 2022-03-18
• Device Publish Date: 2022-03-10

On-Brand Devices [DC-Air™ Intraoral Sensor]

• 64298105870606: DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of
• 06429810587008: DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of
• 06429810587220: DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of