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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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PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.08.xx
In Commercial Distribution

  • B087PATTERNS02081 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
22.01.xx
In Commercial Distribution

  • B087PATT22011 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2024.2.xxx
In Commercial Distribution

  • B087PATT202421 ()


  • Obstetrical monitoring/analysis software
Dentbird Crown is a software intended to support dental prostheses(crowns, bridges, in/onlays) design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin line, and initial values for dental prostheses(crowns, bridges, in/onlays) design using deep learning models and CAD algorithms. Additionally, users can directly modify the suggested design. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj).
IMAGOWORKS Inc.
V.4.X.X
In Commercial Distribution

  • 08809953520021 ()


  • Dental milling system, CAD/CAM, chairside
Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin lines, and initial values for a dental crown design using a deep learning model and CAD algorithm. Additionally, users can directly design the dental crown. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj).
IMAGOWORKS Inc.
V.3.X.X
In Commercial Distribution

  • 08809953520014 ()


  • Dental milling system, CAD/CAM, chairside
Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin lines, and initial values for a dental crown design using a deep learning model and CAD algorithm. Additionally, users can directly design the dental crown. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj).
IMAGOWORKS Inc.
Dentbird Crown V.2.x.x
Not in Commercial Distribution

  • 08809953520007 ()


  • Dental milling system, CAD/CAM, chairside
No Description
MIDMARK CORPORATION
41-0001-6049-3
In Commercial Distribution

  • 00841709112041 ()
78040

  • Dental milling system, CAD/CAM, chairside
No Description
MIDMARK CORPORATION
78-8150-2258-3
In Commercial Distribution

  • 00841709112034 ()
75030

  • Dental milling system, CAD/CAM, chairside
No Description
MIDMARK CORPORATION
70-2014-0340-2
In Commercial Distribution

  • 00841709112027 ()
78032

  • Dental milling system, CAD/CAM, chairside
No Description
Medit Corp.
MO1-PD1
In Commercial Distribution

  • 08800026700470 ()


  • Dental milling system, CAD/CAM, chairside
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