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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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GRADIA® - D0470022791

GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) A2, & 4 tips
Gc America Inc.
002279
In Commercial Distribution

  • D0470022791 ()

  • Weight: 1.5 Gram
002279

  • Light-cured dental restorative composite resin

GRADIA® - D0470022781

GRADIA® DIRECT Flo - 2 syringes (1.5 g/0.8 mL per syringe) A1, & 4 tips
Gc America Inc.
002278
In Commercial Distribution

  • D0470022781 ()

  • Weight: 1.5 Gram
002278

  • Light-cured dental restorative composite resin

GC Fuji ORTHO™ - D0470018881

GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) cartridges & 1 x mixing pad)
Gc America Inc.
001888
In Commercial Distribution

  • D0470018881 ()

  • Weight: 13.3 Gram
001888

  • Glass ionomer dental cement

GC Fuji LINING™ - D0470018871

GC Fuji LINING™ (1 x 7 g (4.7 mL) cartridge, 1 x mixing pad)
Gc America Inc.
001887
In Commercial Distribution

  • D0470018871 ()

  • Weight: 7 Gram
001887

  • Dental cavity liner

Renamel Microfill Pediatric Kit - D779607PED3

Renamel Microfill Pediatric Kit include 5 (4 g) syringes of Renamel Microfill in the Tray.
COSMEDENT, INC.
607PED
In Commercial Distribution

  • D779607PED3 ()
607PED

  • Dental composite resin

Renamel Microhybrid Pedo Kit - D779606PED3

Renamel Microhybrid Pedo Kit includes 5 (5 g) syringes of Renamel Microhybrid in the Tray.
COSMEDENT, INC.
606PED
In Commercial Distribution

  • D779606PED3 ()
606PED

  • Dental composite resin

HELMUT ZEPF - EZPF64095080040

ELEVATOR, ENT TATUM SINUS MEMBR. ELEVATOR 4MM/4MM AS PER CUSTOMER DRAWING# 01-8264 REV G
Helmut Zepf Medizintechnik GmbH
64095.08.004
In Commercial Distribution

  • EZPF64095080040 ()
64095.08.004

  • Periosteal elevator, reusable

Ena HRI ® - EMICEHTOA1

Ena HRi Opalescent Amber Enamel OA 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHTOA
In Commercial Distribution

  • EMICEHTOA1 ()
  • EMICCOSVITOA0 ()

  • Weight: 3.6 Gram
EHTOA

  • Dental composite resin

Ena HRI ® - EMICEHRTIW1

Ena HRi Intensive White Enamel IW 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTIW
In Commercial Distribution

  • EMICEHRTIW1 ()
  • EMICCOSVITIW0 ()

  • Weight: 3.6 Gram
EHRTIW

  • Dental composite resin

Ena HRI ® - EMICEHRTIM1

Ena HRi Intensive Milky Enamel IM 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTIM
In Commercial Distribution

  • EMICEHRTIM1 ()
  • EMICCOSVITIM0 ()

  • Weight: 3.6 Gram
EHRTIM

  • Dental composite resin
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