DentiqAir

GUDID 08800022900072

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.

3D Industrial Imaging Co.,Ltd

Radiology DICOM image processing application software

• Primary Device ID: 08800022900072
• NIH Device Record Key: ccf5a9ac-fe4e-46e9-a969-97d9bdb4365e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentiqAir
• Version Model Number: 1.0
• Company DUNS: 688269503
• Company Name: 3D Industrial Imaging Co.,Ltd
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net
• Phone: +827087669192
• Email: service@3dii.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800022900072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183676

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-01-06
• Device Publish Date: 2020-12-29

Devices Manufactured by 3D Industrial Imaging Co.,Ltd

• 08800022900072 - DentiqAir: 2021-01-06DentiqAir 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.
• 08800022900072 - DentiqAir: 2021-01-06 DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial regi
• 08800022900089 - VARO Plan: 2021-01-06 VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation
• 08800022900041 - DentiqGuide: 2019-10-07 DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s C