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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The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software
Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer
XiVE® TG Lab Set Gold Bar Coping
Dentsply Implants Manufacturing GmbH
32259600
Not in Commercial Distribution

  • EFRI322596002 ()
25-9600

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259301
Not in Commercial Distribution

  • EFRI322593012 ()
25-9301

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259300
Not in Commercial Distribution

  • EFRI322593002 ()
25-9300

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32254106
Not in Commercial Distribution

  • EFRI322541062 ()
25-4106

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32254105
Not in Commercial Distribution

  • EFRI322541052 ()
25-4105

  • Dental implant suprastructure kit
TG Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492692
In Commercial Distribution

  • 00630414580722 ()
10492692

  • Thyroglobulin antibody IVD, control
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