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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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Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), and one PermaSoft Soft Denture Liner Kit (N811100), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package
Not in Commercial Distribution

  • D0019055850 ()
905585

  • Dental appliance fabrication material, resin
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
No Description
Dentsply International Inc.
Eclipse Bonding Agent
Not in Commercial Distribution

  • D0019055450 ()

  • Weight: 180 Gram
905545

  • Dental appliance fabrication material, resin
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
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
Light Pink
Dentsply International Inc.
Contour Resin
Not in Commercial Distribution

  • D0019050930 ()
  • D0019049918 ()
905093

  • Dental appliance fabrication material, resin
Clear
Dentsply International Inc.
Lower Baseplate Resin
Not in Commercial Distribution

  • D0019050860 ()
  • D0019050738 ()
905086

  • Dental appliance fabrication material, resin
Light Pink
Dentsply International Inc.
Lower Baseplate Resin
Not in Commercial Distribution

  • D0019050820 ()
  • D0019049878 ()
905082

  • Dental appliance fabrication material, resin
No Description
Dentsply International Inc.
Sealer
Not in Commercial Distribution

  • D001N8160050 ()

  • Total Volume: 105 Milliliter
N816005

  • Dental appliance fabrication material, resin
No Description
Dentsply International Inc.
Sealer
Not in Commercial Distribution

  • D001N8160020 ()

  • Total Volume: 30 Milliliter
N816002

  • Dental appliance fabrication material, resin
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