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 Class Implantable

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No Description
PRIMOTEC LLC
PS100US
In Commercial Distribution

  • D831PS100US1 ()
  • D831PS100US0 ()


  • Dental occlusal splint, custom-made
DELTASPLINT, 12 Rods
DeltaMed GmbH
1370010
In Commercial Distribution

  • EDEL13700100 ()
  • EDEL13700101 ()
1370010

  • Dental occlusal splint, custom-made
No Description
ICP, INC.
51-9597150
In Commercial Distribution

  • D7715195971500 ()
  • D7715195971501 ()


  • Dental appliance fabrication material, thermoplastic
No Description
ICP, INC.
51-9597090
In Commercial Distribution

  • D7715195970900 ()
  • D7715195970901 ()


  • Dental appliance fabrication material, thermoplastic
No Description
ICP, INC.
51-9596980
In Commercial Distribution

  • D7715195969800 ()
  • D7715195969801 ()


  • Dental appliance fabrication material, thermoplastic
No Description
Amann Girrbach AG
Ceramill A-Splint 98x20
In Commercial Distribution

  • E4947610861 ()
761248

  • Temporary dental crown/bridge
No Description
Amann Girrbach AG
Ceramill A-Splint 98x16
In Commercial Distribution

  • E4947610851 ()
761248

  • Temporary dental crown/bridge
No Description
Amann Girrbach AG
Ceramill A-Splint 98x14
In Commercial Distribution

  • E4947610841 ()
761248

  • Temporary dental crown/bridge
No Description
Amann Girrbach AG
Ceramill A-Splint 71x20
In Commercial Distribution

  • E4947610821 ()
761248

  • Temporary dental crown/bridge
No Description
Amann Girrbach AG
Ceramill A-Splint 71x16
In Commercial Distribution

  • E4947610811 ()
761248

  • Temporary dental crown/bridge
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