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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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PermaSoft® - D001N8121000

Contains one (1) 120 gram powder (Clear), two (2) 60 milliliter liquids, and one (1) 30 milliliter sealer
Dentsply International Inc.
Soft Denture Liner 120 G Kit Clear
Not in Commercial Distribution

  • D001N8121000 ()
N812100

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8120000

Contains one (1) 120 gram powder (Pink), two (2) 60 milliliter liquids, and one (1) 30 milliliter sealer
Dentsply International Inc.
Soft Denture Liner 120 G Kit Pink
Not in Commercial Distribution

  • D001N8120000 ()
N812000

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8116000

Contains one (1) PermaSoft® Combination Kit (N811500) and one (1) PermaSoft® Trial Kit (N811400)
Dentsply International Inc.
Promotional Pack
Not in Commercial Distribution

  • D001N8116000 ()
N811600

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8115000

Contains one (1) 60 gram powder (Pink), one (1) 30 gram powder (Clear), one (1) 60 milliliter liquid, and one (1) 30 milliliter sealer
Dentsply International Inc.
Soft Denture Liner Combination Kit
Not in Commercial Distribution

  • D001N8115000 ()
N811500

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8114000

Contains one (1) 30 gram PermaSoft Powder Pink (N815001), one (1) 30 milliliter PermaSoft Liquid (N814001), and one (1) 15 milliliter PermaSoft Sealer (N811300). Items are not sold individually.
Dentsply International Inc.
Trial Kit
Not in Commercial Distribution

  • D001N8114000 ()
N811400

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8111000

Contains one (1) 60 gram powder (N815102), one (1) 60 milliliter liquid (N814002), and one (1) 30 milliliter sealer (N816002)
Dentsply International Inc.
Soft Denture Liner 60 G Kit Clear
Not in Commercial Distribution

  • D001N8111000 ()
N811100

  • Dental appliance fabrication material, resin

PermaSoft® - D001N8110000

Contains one (1) 60 gram powder (N815002), one (1) 60 milliliter liquid (N814002), and one (1) 30 milliliter sealer (N816002)
Dentsply International Inc.
Soft Denture Liner 60 G Kit Pink
Not in Commercial Distribution

  • D001N8110000 ()
N811000

  • Dental appliance fabrication material, resin

Therm-o-Flex® - D001N4061600

Acetal Resin
Dentsply International Inc.
Pink
Not in Commercial Distribution

  • D001N4061600 ()

  • Weight: 220 Gram
N406160

  • Dental appliance fabrication material, thermoplastic

Therm-o-Flex® - D001N4061490

Acetal Resin
Dentsply International Inc.
Bleach 3
Not in Commercial Distribution

  • D001N4061490 ()

  • Weight: 220 Gram
N406149

  • Dental appliance fabrication material, thermoplastic

Therm-o-Flex® - D001N4061480

Acetal Resin
Dentsply International Inc.
Bleach 2
Not in Commercial Distribution

  • D001N4061480 ()

  • Weight: 220 Gram
N406148

  • Dental appliance fabrication material, thermoplastic
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