Ortho System

Basic Information

• Brand Name: Ortho System
• Primary DI: 05902729752510
• Version / Model: 2017-1
• Company Name: 3shape A/S
• Labeler DUNS: 306826012
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-30
• Public Version: 5
• Public Version Date: 2023-02-10
• Public Version Status: Update
• Public Device Record Key: 32b90869-3c8c-4343-af79-4c95077fa344
• Distribution End Date: 2022-10-06

Device Description

CAD/CAM software

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNN	Othodontic Software	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50484	CAD/CAM software	A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05902729752510	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171634	000