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Acteon

FDA UDI

Class II (US FDA UDI)

by Sopro

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Diagnostic-imaging multiformat camera FDA UDI
Device Name
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. FDA UDI
Model / Reference
KIT SOPROCARE NTSC with Mini Dock USB2 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
S_K50_1111 FDA UDI
Primary DI / UDI-DI
03760278260113 FDA UDI
FDA Product Code
NYH FDA UDI
GMDN Term
Diagnostic-imaging multiformat camera FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic-imaging multiformat camera

Acteon by Sopro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic-imaging multiformat camera.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sopro

Sources (1)

  • FDA UDI 91d22474-d979-4d09-9b37-fddb963b62d0 35 fields · synced May 30, 2026