3Shape F8

GUDID 05902729753791

The 3Shape F8 is used to record the topographical characteristics of the dentition by scanning objects, for example teeth, dental gypsum or impression models that can include scan bodies. A 3D model is created, which can further be annotated and corrected for scan artifacts.

3shape Trios A/S

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• Primary Device ID: 05902729753791
• NIH Device Record Key: c8108e14-677b-4a86-a449-8b84542c6073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Shape F8
• Version Model Number: P7-4111
• Company DUNS: 305225025
• Company Name: 3shape Trios A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902729753791 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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: 2023-04-04
• Device Publish Date: 2023-01-18

Devices Manufactured by 3shape Trios A/S

• 05902729753838 - Trios Move+: 2023-09-14
• 05902729753791 - 3Shape F8: 2023-04-04The 3Shape F8 is used to record the topographical characteristics of the dentition by scanning objects, for example teeth, dental gypsum or impression models that can include scan bodies. A 3D model is created, which can further be annotated and corrected for scan artifacts.
• 05902729753791 - 3Shape F8: 2023-04-04 The 3Shape F8 is used to record the topographical characteristics of the dentition by scanning objects, for example teeth, denta
• 05902729753272 - TRIOS Patient Monitoring: 2023-02-15 Monitoring of changes in the dentition over time by comparison of TRIOS 3D images
• 05902729753746 - TRIOS: 2022-10-04
• 05902729753678 - TRIOS: 2022-10-04
• 05902729753685 - TRIOS: 2022-10-04
• 05902729753722 - TRIOS 5: 2022-10-04
• 05902729753739 - TRIOS 5: 2022-10-04