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510(k) Data Aggregation
K Number
K223470Device Name
C50
Manufacturer
SOPRO
Date Cleared
2023-12-14
(392 days)
Product Code
NBL
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
SOPRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C50 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 invisible to the naked eye or with a mirror (thanks to magnification).
Device 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 inflammation that leads 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).
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K Number
K153701Device Name
ULYSS Multi View Sinuscope
Manufacturer
SOPRO-COMEG GMBH
Date Cleared
2016-09-09
(261 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
SOPRO-COMEG GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Device Description
The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope.
The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler.
The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use.
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K Number
K153367Device Name
S698 Symbioz flow
Manufacturer
SOPRO - ACTEON GROUP
Date Cleared
2016-06-17
(207 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
SOPRO - ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This apparatus is an insufflator for performing laparoscopic procedures. It was designed for the purpose of creating the pneumoperitoneum (distension of the abdominal cavity with CO2) as part of these procedures.
Device Description
Not Found
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K Number
K142995Device Name
SOPIX
Manufacturer
SOPRO - ACTEON GROUP
Date Cleared
2015-08-17
(305 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOPRO - ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
Device Description
The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
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K Number
K151053Device Name
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner
Manufacturer
SOPRO - ACTEON GROUP
Date Cleared
2015-07-31
(102 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOPRO - ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates.
Device Description
The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates.
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K Number
K140013Device Name
SOPIX INSIDE, SOPIX2 INSIDE
Manufacturer
SOPRO - ACTEON GROUP
Date Cleared
2014-09-05
(246 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOPRO - ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.
Device Description
The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.
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K Number
K121685Device Name
SOPROCARE
Manufacturer
SOPRO
Date Cleared
2013-03-12
(278 days)
Product Code
NBL, NYH
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
SOPRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The New Device 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 invisible to the naked eye or with a mirror (thanks to its magnification).
Device Description
The New Device is an intra-oral video camera equipped with LEDs to light the inspection site. Thanks to its technology based on fluorescence phenomenon (given by its LED lamps) and chromatic amplification, this camera will permit a global care of the patient. The optics and the charge coupled device (CCD) sensor in the New Device picks up the images containing this fluorescence highlight site and converts them to a video signal that is sent to a video monitor or computer monitor. Dental practitioner and/or hygienist, as an aid for diagnosis, can use the results of this image.
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K Number
K103813Device Name
SOPRO 281
Manufacturer
SOPRO
Date Cleared
2011-03-22
(83 days)
Product Code
NTN, FCW
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SOPRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy
Device Description
The SOPRO 281 is a light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable. A switch on the top of the device enables light output and intensity control. A multi-color led indicates device status
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K Number
K092329Device Name
SOPIX 2
Manufacturer
SOPRO
Date Cleared
2010-07-20
(350 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOPRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOPIX 2 SYSTEM is intended to be used by qualified dentist in general to provide instant X-Ray images, typically of tooth, bone and surrounding tissues.
Device Description
The SOPIX2 system is a digital x-ray sensor system for human and non human use in dental and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.
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K Number
K092583Device Name
SOPROLIFE
Manufacturer
SOPRO
Date Cleared
2010-01-13
(145 days)
Product Code
NBL
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
SOPRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOPROLIFE is indicated as an aid in the diagnosis of dental caries and as an intra oral camera to visualize anatomical details invisible to the naked eye or with mirror.
Device Description
The SOPROLIFE is a fluorescence caries detection device . This device is a fluorescence detector housed in a dental handpiece, and a control unit that performs device calibration, as well as variable tone emitting and fluorescence measurement functions.
The handbiece can be connected with 5 different control units : Dock M VIDEO Dock M USB2. Dock MU VIDEO, Dock MU USB2, Dock USB2.
The SOPROLIFE is a device used in clinical dental applications to observe the condition of hard dentinal tissues.
As the SOPROLIFE can be adapted to the most complex of clinical situations, it quickly helps the dentist to get a complete analysis as it adjusts treatment options in Diagnosis aid mode. In Treatment aid mode, the SOPROLIFE facilitates observation of the dentinal tissue condition in progress and at the end of the treatment. In daylight mode the SOPROLIFE enables the dentist to visualize anatomical details invisible to the naked eye or with mirror like an intra oral camera SOPRO 595.
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