FDA.reportPublic FDA data

ACTEON

Primary DI
03760278267020
Brand
ACTEON
Company
SOPRO
Model
C50 - INTRAORAL CAMERA D
Catalog number
S_C50_0002
Device description
"C50 camera and its single-use protective sheath is intended to visualize anatomical and pathological details that cannot be seen with the naked eye or with a mirror (thanks to its magnification) in DAYLIGHT or DAYLIGHT+ modes. These modes allow the dentist to show difference between ""before"" and ""after"" care, as well as pathology control and post-treatment. C50 does not provide a diagnostic. (Without fluorescence option)"
Published
2022-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760278267037Direct MarkingGS10
03760278267020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760278267037037602782670373760278267037
03760278267020037602782670203760278267020

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral cameraAn electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display.

Contacts#

Phone, Email table
PhoneEmail
+33556340607info@acteongroup.com

Regulatory Flags#

DUNS number
264205501
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760278260434ACTEON SYSTEME PSPIX WIN MAC (Only)9970902018-11-19
03760278260939ACTEON SYSTEME PSPIX WIN MACS_702_00112018-11-19
M430S70200111ACTEON SYSTEME PSPIX WIN MACS_702_00112016-09-24
03760278267587ACTEONC50 - INTRAORAL CAMERAS_C50_00082024-05-02
03760278267594ACTEONC50 - INTRAORAL CAMERA DS_C50_00092024-05-02
03760278267037ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278260045COMEG MEDICAL TECHNOLOGIESUBIPACK ENT SYSTEMSK1010162017-12-19
03760278260427COMEG MEDICALSOURCE LED SOPRO 281 BLANC (Only)9983602018-11-19
M430S21800061COMEG MEDICALSOPRO 218 - SOURCE DE LUMIERE XENON 180W - SOPRO S_218_00062016-09-24
M430S21800091COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00092016-09-24
M430S21800111COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00112016-09-24
M430S21800121COMEG MEDICALS218 SOPRO US WOLFS_218_00122016-09-24
M430S23000051COMEG MEDICALSOPRO 230 - SOURCE DE LUMIERE XENON 300W - SOPROS_230_00052016-09-24
M430S23000091COMEG MEDICALS230 SOPRO US OLYMPUSS_230_00092016-09-24
M430S23000111COMEG MEDICALS230 SOPRO US WOLFS_230_00112016-09-24
M430S28100011COMEG MEDICALSOURCE LED SOPRO 281 ORLS_281_00012016-09-24
M430S28100021COMEG MEDICALSOURCE LED SOPRO 281 BLANCS_281_00022016-09-24
M430S29800021COMEG MEDICALSOURCE LED SOPRO S298S_298_00022016-09-24
03760278260342COMEG MEDICAL TECHNOLOGIESPENTAX Medical LED Light SourceS_281P_01042019-07-16
03760278260380COMEG MEDICAL TECHNOLOGIESPENTAX Medical USB CameraS_181P_01122019-07-16

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Primary DI, Brand, Company table
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