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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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Lucitone® HIPA - D0019059260

Pink
Dentsply International Inc.
25-Unit Package
In Commercial Distribution

  • D0019059260 ()

  • Weight: 500 Gram


  • Dental appliance fabrication material, resin

Lucitone® HIPA - D0019059250

Dark Pink
Dentsply International Inc.
25-Unit Package
In Commercial Distribution

  • D0019059250 ()

  • Weight: 500 Gram
905925

  • Dental appliance fabrication material, resin

Lucitone® FRS® - D0019058550

No Description
Dentsply International Inc.
Small Light Reddish Pink
Not in Commercial Distribution

  • D0019058550 ()
  • D0019058558 ()

  • Weight: 15 Gram
905855

  • Dental appliance fabrication material, thermoplastic

Lucitone® FRS® - D0019058540

No Description
Dentsply International Inc.
Small Light Pink
Not in Commercial Distribution

  • D0019058540 ()
  • D0019058548 ()

  • Weight: 15 Gram
905854

  • Dental appliance fabrication material, thermoplastic

Lucitone® FRS® - D0019058530

No Description
Dentsply International Inc.
Small Original
Not in Commercial Distribution

  • D0019058530 ()
  • D0019058538 ()

  • Weight: 15 Gram
905853

  • Dental appliance fabrication material, thermoplastic

Lucitone® FRS® - D0019058520

No Description
Dentsply International Inc.
Small Clear
Not in Commercial Distribution

  • D0019058520 ()
  • D0019058528 ()

  • Weight: 15 Gram
905852

  • Dental appliance fabrication material, thermoplastic

Eclipse® - D0019056500

Contains: three 12-pack Eclipse Clear Upper Baseplate Resin (905006), three 12-pack Eclipse Clear Lower Baseplate Resin (905012), and two 60-pack Eclipse Resilient Resin (906180), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package Night Guard Assortment
Not in Commercial Distribution

  • D0019056500 ()
905650

  • Dental appliance fabrication material, resin

Eclipse® - D0019056450

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), one PermaSoft Soft Denture Liner Kit (N811100), and one Eclipse Bonding Agent Kit (905550), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package with Bonding Agent
Not in Commercial Distribution

  • D0019056450 ()
905645

  • Dental appliance fabrication material, resin

Eclipse® - D0019056200

No Description
Dentsply International Inc.
Eclipse Wax Remover
Not in Commercial Distribution

  • D0019056200 ()

  • Total Volume: 100 Milliliter
905620

  • Dental appliance fabrication material, resin

Eclipse® - D0019055850

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
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