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510(k) Data Aggregation
K Number
K070535Device Name
RETROPAN CCD-TWAIN-USB
Manufacturer
Date Cleared
2007-04-24
(57 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
VIDEO DENTAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RetroPan CCD -- TWAIN - USB Digital X-ray Conversion Kit from Video Dental Concepts, Inc. is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.
The RetroPan CCD - TWAIN - USB sensor produces instant digital images. The RetroPan CCD - TWAIN - USB allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K-12439, which gives post processing capabilities to enhance images.
It is faster to obtain images with the RetroPan CCD – TWAIN – USB Retrofit Kit than from conventional film since no chemical nor any other type of processing is required.
Device Description
The RetroPan CCD - TWAIN - USB Digital X-ray Conversion Kit is a sensor connected to the DentalEye software, #K-12439.
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K Number
K020957Device Name
ORACAM
Manufacturer
Date Cleared
2002-06-13
(80 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
VIDEO DENTAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment.
The OraCam is therefore similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems, in its intended use.
Device Description
Not Found
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K Number
K001541Device Name
MINICAM
Manufacturer
Date Cleared
2000-07-21
(65 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
VIDEO DENTAL CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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