3Shape Ortho System

GUDID 05902768365283

3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuri

3shape A/S

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software

• Primary Device ID: 05902768365283
• NIH Device Record Key: d9833a85-da28-468e-95b7-bf749b3aa518
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Shape Ortho System
• Version Model Number: 2015-1
• Company DUNS: 306826012
• Company Name: 3shape A/S
• 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: 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: +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
• 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
• 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	05902768365283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152086

FDA Product Code

• PNN: Othodontic Software

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

Devices Manufactured by 3shape A/S

• 05902729753913 - Automate: 2024-01-30 Automate automatically generates designs and manufacturing files for certain dental CAD orders.
• 05902729753845 - Implant Studio: 2023-08-04 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who h
• 05902729753821 - Automate: 2023-04-05 The 3Shape Automate software is a web service for automatic design of crowns
• 05902729753692 - Implant Studio: 2023-03-03 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who h
• 05902729752220 - Anatomy Design: 2022-02-21 Dental CAD Software
• 05902729753531 - Puffin: 2021-06-08 The Puffin service is intended to aid in the design of dental restorative prosthetics.
• 05902729752787 - Ortho System: 2021-06-04 CAD/CAM software
• 05902729752954 - Splint Design: 2021-06-04 Dental treatment application software