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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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Eclipse® - D0019055500

No Description
Dentsply International Inc.
Bonding Agent Kit
Not in Commercial Distribution

  • D0019055500 ()

  • Total Volume: 6.3 Fluid Ounce
905550

  • Dental appliance fabrication material, resin

Eclipse® - D0019055450

No Description
Dentsply International Inc.
Eclipse Bonding Agent
Not in Commercial Distribution

  • D0019055450 ()

  • Weight: 180 Gram
905545

  • Dental appliance fabrication material, resin

Triad® - D0019055370

No Description
Dentsply International Inc.
DuaLine® Refill Package
Not in Commercial Distribution

  • D0019055370 ()
  • D0019055368 ()

  • Weight: 56 Gram
  • Contains two (2) 56 gram DuaLine cartridges,
905537

  • Dental appliance fabrication material, resin

Triad® - D0019055300

No Description
Dentsply International Inc.
DuaLine® Introductory Package
Not in Commercial Distribution

  • D0019055300 ()

  • Contains two (2) 56 gram DuaLine cartridges One (1) 20 millileter Bonding Agent
905530

  • Dental appliance fabrication material, resin

Eclipse® - D0019052750

Contains: 11 12-pack boxes of Eclipse resins, Bonding Agent Kit, and miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Kit #2
Not in Commercial Distribution

  • D0019052750 ()
905275

  • Dental appliance fabrication material, resin

Eclipse® - D0019052610

Variety Pack
Dentsply International Inc.
Upper Baseplate Resin
Not in Commercial Distribution

  • D0019052610 ()

  • Contains six sheets of Light Pink, 3 sheets of Light Reddish Pink, and 3 sheets of Dark Pink
905261

  • Dental appliance fabrication material, resin

Eclipse® - D0019050940

Light Reddish Pink
Dentsply International Inc.
Contour Resin
Not in Commercial Distribution

  • D0019050940 ()
  • D0019049928 ()
905094

  • Dental appliance fabrication material, resin

Eclipse® - D0019050930

Light Pink
Dentsply International Inc.
Contour Resin
Not in Commercial Distribution

  • D0019050930 ()
  • D0019049918 ()
905093

  • Dental appliance fabrication material, resin

Eclipse® - D0019050920

Original
Dentsply International Inc.
Contour Resin
Not in Commercial Distribution

  • D0019050920 ()
  • D0019049898 ()
905092

  • Dental appliance fabrication material, resin

Eclipse® - D0019050870

Original
Dentsply International Inc.
Set-Up Resin
Not in Commercial Distribution

  • D0019050870 ()
  • D0019049938 ()
905087

  • Dental appliance fabrication material, resin
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