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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. Logicon Caries Detector v5.2 has a "Prescan" feature, a method for automatically scanning all of the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen combining his own manual results and adjusted PreScan results. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface.
G. A Industries
5.2
Not in Commercial Distribution

  • 00868430000027 ()


  • General-purpose dental x-ray system application software
Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. PreScan is a New Feature in Logicon Caries Detector v5.1. It is a method for automatically scanning all the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface.
G. A Industries
5.1
Not in Commercial Distribution

  • 00868430000010 ()


  • General-purpose dental x-ray system application software
Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability.
G. A Industries
4.0
Not in Commercial Distribution

  • 00868430000003 ()


  • General-purpose dental x-ray system application software
T LOK CERVICAL PLATE 4 LEVEL 18 MM X 93 MM
G SURGICAL LLC
CTL-41893
In Commercial Distribution

  • M999CTL418930 ()
CTL-41893

  • Bone-screw internal spinal fixation system, non-sterile
4.0 mm x12 mm Length, Cortical
G SURGICAL LLC
CSS-04012
In Commercial Distribution

  • M999CSS040120 ()
CSS-04012

  • Bone-screw internal spinal fixation system, non-sterile
Locking Screw 1.8 mm x 3 mm
G SURGICAL LLC
CSS-01803
In Commercial Distribution

  • M999CSS018030 ()
CSS-01803

  • Bone-screw internal spinal fixation system, non-sterile
FIT CHECKER™ Advanced 1:1 Package (1 x 55 g base, 1 x 50 g catalyst), retarder & mixing pad
Gc America Inc.
004903
In Commercial Distribution

  • 14548161282437 ()
004903

  • Silicone dental impression material
FIT CHECKER™ Advanced 1:1 Package (1 x 55 g base, 1 x 50 g catalyst), retarder & mixing pad
Gc America Inc.
004903
In Commercial Distribution

  • D0470049031 ()
004903

  • Silicone dental impression material
No Description
Biomet Orthopedics, LLC
31-301327
In Commercial Distribution

  • 00880304506244 ()

  • SIZE G 70MM STANDARD OFFSET
31-301327

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-301347
In Commercial Distribution

  • 00880304506237 ()

  • SIZE G 80MM STANDARD OFFSET
31-301347

  • Femoral stem prosthesis trial
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