ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: 03760278260120
• Version / Model: KIT SOPROLIFE PAL with Mini Dock USB2
• Catalog Number: S_K50_1112
• Company Name: SOPRO
• Labeler DUNS: 264205501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-12
• Public Version: 2
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: ca20b450-2a98-4821-911b-016f287db93e

Device Description

"In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
NBL	Laser,Fluorescence Caries Detection	Dental	872.1745	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35580	Diagnostic-imaging multiformat camera	An electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760278260120	GS1

Customer Contacts

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