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
Primary Device ID05902768365283
NIH Device Record Keyd9833a85-da28-468e-95b7-bf749b3aa518
Commercial Distribution StatusIn Commercial Distribution
Brand Name3Shape Ortho System
Version Model Number2015-1
Company DUNS306826012
Company Name3shape A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105902768365283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNNOthodontic Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-05

Devices Manufactured by 3shape A/S

05902729754019 - Automate2024-10-07 Automate is intended to generate design and manufacturing files for dental restorative prosthetics and dental appliances. Automa
05902729753913 - Automate2024-01-30 Automate automatically generates designs and manufacturing files for certain dental CAD orders.
05902729753845 - Implant Studio2023-08-04 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who h
05902729753821 - Automate2023-04-05 The 3Shape Automate software is a web service for automatic design of crowns
05902729753692 - Implant Studio2023-03-03 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who h
05902729752220 - Anatomy Design2022-02-21 Dental CAD Software
05902729753531 - Puffin2021-06-08 The Puffin service is intended to aid in the design of dental restorative prosthetics.
05902729752787 - Ortho System2021-06-04 CAD/CAM software

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