3D Industrial Imaging Co.,Ltd 1.0 DentiqAir
Company Name
3D Industrial Imaging Co.,Ltd
Catalog Number
1.0
Description
DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance.
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Summary
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Additional Details
Device Identifier
08800022900072
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
No
Is Single Use
No
Barcode Mapping
Unit of Measurement | Eaches | GTIN |
---|---|---|
Each | 1 | 08800022900072 |