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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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Disposable Prophy Angles
Premium Plus International Limited
B-CTS3399-60YL
In Commercial Distribution

  • D838BCTS339960YL2 ()
  • D838BCTS339960YL0 ()
  • D838BCTS339960YL8 ()


  • Dental polishing cup, single-use
Vinyl Polysiloxane Impression Cartridge, Heavy Body, Regular Set, 50ml (1)
ALPINE DENTAL INC.
AD311
In Commercial Distribution

  • D922VPSAD3101 ()
  • D922VPSAD3110 ()
VPSAD311

  • Silicone dental impression material
Vinyl Polysiloxane Impression Cartridge, Heavy Body, Fast Set, 50ml (1)
ALPINE DENTAL INC.
AD301
In Commercial Distribution

  • D922VPSAD3010 ()
  • D922VPSAD3001 ()
VPSAD301

  • Silicone dental impression material
Vinyl Polysiloxane Impression Cartridge, Injection, Fast Set, 50ml (1)
ALPINE DENTAL INC.
AD101
In Commercial Distribution

  • D922VPSAD1011 ()
  • D922VPSAD1001 ()
VPSAD101

  • Silicone dental impression material
Bite Registration Cartridge, Fast Set, 50ml (1)
ALPINE DENTAL INC.
AD616
In Commercial Distribution

  • D922BRAD6151 ()
  • D922BRAD6160 ()
BRAD616

  • Silicone dental impression material
Saliva Ejector White with White Tip
Plastcare USA
WHW
In Commercial Distribution

  • D915WHW2 ()
  • D915WHW1 ()
  • D915WHW0 ()


  • Dental suction system cannula, single-use
Utility syringe curved 12cc
Plastcare USA
S12CC
In Commercial Distribution

  • D915S12CC2 ()
  • D915S12CC1 ()
  • D915S12CC0 ()


  • Dental impression material syringe, single-use
Isolation Gown with Knit Cuffs - Pink
Plastcare USA
RIT-G30P
In Commercial Distribution

  • D915RITG30P2 ()
  • D915RITG30P1 ()
  • D915RITG30P0 ()


  • Professional examination gown, single-use
Isolation Gown with Knit Cuffs - Blue
Plastcare USA
RIT-G30B
In Commercial Distribution

  • D915RITG30B2 ()
  • D915RITG30B1 ()
  • D915RITG30B0 ()


  • Professional examination gown, single-use
(7 1/2" x 14") Sterilization Pouches
Plastcare USA
RIT-7514
In Commercial Distribution

  • D915RIT75141 ()
  • D915RIT75142 ()
  • D915RIT75140 ()


  • Sterilization packaging, single-use
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