ACTEON S_950_0003

GUDID M430S95000031

The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror (thanks to its magnification). In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing). This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition.

SOPRO

Diagnostic-imaging multiformat camera

• Primary Device ID: M430S95000031
• NIH Device Record Key: eee43636-7ba2-4645-ad3e-52eb8b31c51d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTEON
• Version Model Number: CAMERA S950 PAL SOPROCARE WS
• Catalog Number: S_950_0003
• Company DUNS: 264205501
• Company Name: SOPRO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com
• Phone: +33556340607
• Email: info@acteongroup.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M430S95000031 [Primary]

FDA Product Code

• NYH: Plaque Disclosing Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-12-04
• Device Publish Date: 2016-09-24

On-Brand Devices [ACTEON]

• M430S70200111: "The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-r
• 03760278260939: "The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-r
• 03760278260434: "The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-r
• 03760278261516: This is an extra- and intra-oral camera designed for dental applications. It allows the user to
• 03760278261394: This is an extra- and intra-oral camera designed for dental applications. It allows the user to
• M430S95000041: The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis
• M430S95000031: The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis
• M430S95000021: The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis
• M430S90000041: "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at vari
• M430S90000021: "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at vari
• M430S71716001: Dock for dental camera
• M430S71715081: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• M430S71715071: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• M430S71715061: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• M430S71715041: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• M430S71715031: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• M430S71715021: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• M430S71715011: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• M430S71710771: "The DOCK MU_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• M430S71710761: "The DOCK MU_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• M430S71710611: "The DOCK MU_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• M430S71710361: "The DOCK MU_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278263251: Sub-Component - Product alone (without Box and accessories) "The MINI DOCK U_USB2 module are bui
• 03760278262803: The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis
• 03760278262773: "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at vari
• 03760278262650: "The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPRO
• 03760278262643: "The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPRO
• 03760278262575: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278262551: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278262544: "The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPRO
• 03760278262537: "The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPRO
• 03760278262520: "The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPRO
• 03760278262360: "The MINI DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPRO
• 03760278262353: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278262339: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278262322: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278262162: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278262155: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278262100: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• 03760278262094: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• 03760278262087: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• 03760278262063: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• 03760278262056: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• 03760278262049: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• 03760278262032: "The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First
• 03760278261998: "The DOCK U_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278261981: "The DOCK MU_VIDEO module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCAR
• 03760278261974: "The DOCK MU_VIDEO module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCAR
• 03760278261967: "The DOCK MU_USB2 module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE
• 03760278261950: "The DOCK M_VIDEO module are built-in docking stations for SOPRO 617, SOPRO 717 First, SOPROCARE