3Shape

Basic Information

• Brand Name: 3Shape
• Primary DI: 05902768365221
• Version / Model: R500
• Company Name: 3shape A/S
• Labeler DUNS: 306826012
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 3900d05d-9c5b-4880-b62b-ad925d345672
• Distribution End Date: 2018-02-28

Device Description

The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	872.3661	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34713	Dental milling system, CAD/CAM, laboratory	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for production of the actual device(s) for delivery and final fitting to the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05902768365221	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 7000 – 11000 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 7000 – 11000 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius