Automate

GUDID 05902729754019

Automate is intended to generate design and manufacturing files for dental restorative prosthetics and dental appliances. Automate can be used for the following: - Dental prosthetic restorations - Dental appliances

3shape A/S

CAD/CAM software

• Primary Device ID: 05902729754019
• NIH Device Record Key: 83106480-724c-4313-beb7-368281c72f9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automate
• Version Model Number: R2b
• Company DUNS: 306826012
• Company Name: 3shape 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902729754019 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-07
• Device Publish Date: 2024-09-27

On-Brand Devices [Automate]

• 05902729753821: The 3Shape Automate software is a web service for automatic design of crowns
• 05902729753913: Automate automatically generates designs and manufacturing files for certain dental CAD orders.
• 05902729754019: Automate is intended to generate design and manufacturing files for dental restorative prostheti