Acteon

Product alone (without Box and accessories) 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…

Registry build 21.09.26

Product alone (without Box and accessories) 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.

3manufacturers in China registered for this device type
64catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangxi (1), Henan (1), Guangdong (1).

Chinese manufacturers registered for FDA product code NYH
Manufacturer City Province Registered as Device types
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Zhengzhou Huaer Electro-Optics Technology Co., Ltd. Zhengzhou Henan Contract manufacturer 21
Guangzhou Stars Pulse Co., Ltd. Guangzhou Guangdong Manufacturer 3

Record

Regulatory record for Acteon
Listed by Sopro, France
FDA product code NYH
Device type Plaque Disclosing Kit
Device class Class 2
Regulation 21 CFR 872.1740
Establishment Repacker / relabeller, Manufacturer
Record published 2019-03-12
Record revised 2020-12-04 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Acteon
Catalogue number Size Status
54.0225.00 DOCK ANALOG 7M In distribution
54.0293.00 DOCK ANALOG 2M G3 In distribution
MINI DOCK U_USB2 7M In distribution
DOCK MU_VIDEO – ADEC 500 – 5M In distribution
MINI DOCK USB2 In distribution
SOPROCARE N In distribution
DOCK MU USB2 ADEC 300 7M GR3 In distribution
MINI DOCK USB2 STRAUMANN In distribution
DOCK U USB ADEC 500 SURG 1.5M In distribution
DOCK U USB ADEC 300 2M GR3 In distribution
MINI DOCK U_USB2 In distribution
54.0310.00 DOCK ANALOG 2M G3 In distribution
DOCK U_USB2 5M ADEC 500 In distribution
SOPROCARE NTSC In distribution
DOCK U_USB2 5M ADEC 300 In distribution
CAMERA S717 Fisrt NTSC In distribution
SOPROCARE NTSC STRAUMANN In distribution
MINI DOCK U_USB2 7M In distribution
SOPROCARE PAL STRAUMANN In distribution
DOCK MU USB2 ADEC 300 2M GR3 In distribution
MINI DOCK U_USB2 5M In distribution
CAMERA S950 NTSC SOPROCARE WS In distribution
DOCK MU USB2 FUSIBLE ADEC 7M S In distribution
CAMERA S950 PAL SOPROCARE WS In distribution
CAMERA S950 NTSC SOPROCARE In distribution
DOCK U USB BELMONT 7M BIEN AIR In distribution
SOPROCARE NTSC In distribution
DOCK U USB ADEC 500 SURG 1.5M In distribution
MINI DOCK U_USB2 5M In distribution
CONTROLLER – VIDEO – 2.5M In distribution
MINI DOCK U_USB2 5M In distribution
CONTROLLER – USB2 – 2.5M In distribution
MINI USB2 DOCK In distribution
CAMERA S950 NTSC SOPROCARE WS In distribution
DOCK MU USB2 ADEC 300 2M GR3 In distribution
DOCK MU_USB2 – FEDESA – 7M – S In distribution
CAMERA S950 PAL SOPROCARE WS In distribution
DOCK U USB ADEC 300 7M GR3 In distribution
MINI USB2 DOCK In distribution
MINI DOCK U_USB2 1.5M In distribution
SOPROCARE P In distribution
MINI DOCK U_USB2 2M In distribution
DOCK U USB ADEC 500 7M SF6 In distribution
CONTROLLER – VIDEO – 2.5M In distribution
DOCK U USB FEDESA 7M BIEN AIR In distribution
MINI DOCK U_USB2 7M In distribution
MODULE USB2 2M In distribution
MINI DOCK U_USB2 5M In distribution
DOCK MU USB2 ADEC 300 2M GR3 In distribution
DOCK U USB ADEC 500 2M SF6 In distribution
CONTROLLER – USB2 – 2.5M In distribution
KIT SOPROCARE PAL with Mini Dock USB2 In distribution
CAMERA S950 NTSC SOPROCARE In distribution
DOCK U USB ADEC 300 2M GR3 In distribution
DOCK U USB FEDESA 7M BIEN AIR In distribution
DOCK U USB BELMONT 7M BIEN AIR In distribution
KIT SOPROCARE NTSC with Mini Dock USB2 In distribution
DOCK U USB ADEC 500 7M SF6 In distribution
54.0227.00 DOCK ANALOG 2M In distribution
DOCK U USB ADEC 500 2M SF6 In distribution
MINI DOCK U_USB2 7M In distribution
CAMERA S617 NTSC In distribution
54.0584.00 REV A MINI DOCK U_USB2 1M54 In distribution
DOCK U USB ADEC 300 7M GR3 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Owandy Sopro 3
GC Tri Plaque ID Gel™ GC America Inc. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer