DC-Air™ Docking Station

GUDID 64298105870910

DC-Air™ Docking Station is intended for use as a data transfer pathway between the DC-Air™ Intraoral Sensor and a PC or laptop, and as a charging station for the DC-Air™ Intraoral Sensor.

Athlos Oy

Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable Noninvasive device battery charger/transceiver/cable

• Primary Device ID: 64298105870910
• NIH Device Record Key: f1133ed7-24de-4ac9-8b57-fe30235c946b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-Air™ Docking Station
• Version Model Number: WIOS-DS2
• 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	64298105870392 [Primary]
GS1	64298105870910 [Package]; Contains: 64298105870392; 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™ Docking Station]

• 64298105870910: DC-Air™ Docking Station is intended for use as a data transfer pathway between the DC-Air™ I
• 06429810587039: DC-Air™ Docking Station is intended for use as a data transfer pathway between the DC-Air™ I