PrograScan One+

Basic Information

• Brand Name: PrograScan One+
• Primary DI: 05902729753616
• Version / Model: S3-2
• Company Name: 3shape Trios A/S
• Labeler DUNS: 305225025
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-26
• Public Version: 2
• Public Version Date: 2023-10-05
• Public Version Status: Update
• Public Device Record Key: 3e684005-e4bd-4b98-baba-b91c0fe3c242
• Distribution End Date: 2022-05-31

Device Description

Intraoral scanner w. protection tip

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
63669	Intraoral optical scanning system	An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05902729753616	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 120 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 120 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius