DentiqGuide

GUDID 08800022900041

DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock.

3D Industrial Imaging Co.,Ltd

Radiology DICOM image processing application software

• Primary Device ID: 08800022900041
• NIH Device Record Key: df545fc2-ec80-4455-9321-113c10389b37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentiqGuide
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800022900041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180629

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-07-22

Devices Manufactured by 3D Industrial Imaging Co.,Ltd

• 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: 2019-10-07DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock.
• 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