C50 Intraoral Camera Us

EUDAMEDFDA UDI

Class I (EU MDR)

Ref S_C50_0008Model S_C50_0001

by Sopro

Identity

Trade Name: C50 INTRAORAL CAMERA US EUDAMED
ACTEON FDA UDI
Generic Name: Intraoral camera FDA UDI
Device Name: C50 EUDAMED
The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) Showing the difference between “before” and “after” care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing). FDA UDI
Model / Reference: S_C50_0001 EUDAMED
S_C50_0008 EUDAMED
C50 - INTRAORAL CAMERA FDA UDI
Description: The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) Showing the difference between “before” and “after” care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing). FDA UDI

Identifiers

Catalog Number: S_C50_0008 FDA UDI
Primary DI / UDI-DI: 03760278267587 EUDAMEDFDA UDI
Basic UDI-DI: 801337602782D0006CZ EUDAMED
Direct Marketing DI: 03760278266153 EUDAMED
510(k) Number: K223470 FDA UDI
FDA Product Code: NBL FDA UDI
EMDN Code: Z11039010 PHOTO CAMERAS EUDAMED
GMDN Term: Intraoral camera FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 872.1745 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

C50 Intraoral Camera Us by Sopro — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	801337602782D0006CZ	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sopro
EUDAMED SRN: FR-MF-000000833

Sources (2)

EUDAMED b6517c9c-2ec5-45e8-b8e6-c27cbfee8629 61 fields · synced Jun 19, 2026
FDA UDI 66351324-f954-4b81-82e7-81fbc7af5517 36 fields · synced May 30, 2026