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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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EPITEX® - D6584730051

EPITEX® Starter package Contains: 1 Reel each of Coarse, Medium, Fine & Extra Fine strips 5mm wide, 1 Reel of Translucent matrix strip, work station
Gc America Inc.
473005
In Commercial Distribution

  • D6584730052 ()
  • D6584730051 ()
473005

  • Dental abrasive strip, single-use

EPITEX® - D6584730011

EPITEX® Translucent Matrix Strip Refill
Gc America Inc.
473001
In Commercial Distribution

  • D6584730012 ()
  • D6584730011 ()
473001

  • Dental abrasive strip, single-use

GC FujiCEM™ 2 - D6584410011

GC FujiCEM™ 2 Starter Kit (One (7.2mL; 13.3g) cartridge, 20 mixing tips and 1 GC FujiCEM 2 Dispenser)
Gc America Inc.
441001
In Commercial Distribution

  • D6584410011 ()
441001

  • Glass ionomer dental cement

G-CEM™ - D6584390031

G-CEM™ Starter Package (1 x 50 capsule assorted package, 1 x Capsule Applier)
Gc America Inc.
439003
In Commercial Distribution

  • D6584390031 ()
  • D6584390030 ()
439003

  • Silicone dental impression material

GC CROWNTEK™ - D6584121271

GC CROWNTEK™ Refill Size, 5 crowns of one size Premolar 2
Gc America Inc.
412127
Not in Commercial Distribution

  • D6584121271 ()
  • D6584121270 ()
412127

  • Preformed dental crown, temporary

GC CROWNTEK™ - D6584121261

GC CROWNTEK™ Refill Size, 5 crowns of one size Premolar 1
Gc America Inc.
412126
Not in Commercial Distribution

  • D6584121261 ()
  • D6584121260 ()
412126

  • Preformed dental crown, temporary

GC CROWNTEK™ - D6584121251

GC CROWNTEK™ Refill Size, 5 crowns of one size Cuspid Low L. (-3.5)
Gc America Inc.
412125
Not in Commercial Distribution

  • D6584121251 ()
  • D6584121250 ()
412125

  • Preformed dental crown, temporary

GC CROWNTEK™ - D6584121241

GC CROWNTEK™ Refill Size, 5 crowns of one size Cuspid Low L. (-3.4)
Gc America Inc.
412124
Not in Commercial Distribution

  • D6584121241 ()
  • D6584121240 ()
412124

  • Preformed dental crown, temporary

GC CROWNTEK™ - D6584121231

GC CROWNTEK™ Refill Size, 5 crowns of one size Cuspid Low L. (-3.3)
Gc America Inc.
412123
Not in Commercial Distribution

  • D6584121231 ()
  • D6584121230 ()
412123

  • Preformed dental crown, temporary

GC CROWNTEK™ - D6584121221

GC CROWNTEK™ Refill Size, 5 crowns of one size Cuspid Low L. (-3.2)
Gc America Inc.
412122
Not in Commercial Distribution

  • D6584121221 ()
  • D6584121220 ()
412122

  • Preformed dental crown, temporary
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