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

  • 14548161075343 ()

  • Weight: 1.5 Gram
002278

  • Dental composite resin
G-aenial™ JE, 1 syringe (2 mL/3.4 g per syringe) and 15 dispensing tips.
Gc America Inc.
004215
In Commercial Distribution

  • 14548161323321 ()

  • Total Volume: 2 Milliliter
004215

  • Dental composite resin
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 includes 5 (5 g) syringes of Renamel Microhybrid in the Tray.
COSMEDENT, INC.
606PED
In Commercial Distribution

  • D779606PED3 ()
606PED

  • Dental composite resin
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 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 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
Ena HRi Bio Function Enamel BF3 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTBF3
In Commercial Distribution

  • EMICEHRTBF31 ()
  • EMICCOSVITBF30 ()

  • Weight: 3.6 Gram
EHRTBF3

  • Dental composite resin
Ena HRi Bio Function Enamel BF2 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTBF2
In Commercial Distribution

  • EMICEHRTBF21 ()
  • EMICCOSVITBF20 ()

  • Weight: 3.6 Gram
EHRTBF2

  • Dental composite resin
Ena HRi Bio Function Enamel BF1 12 tips x 0.3 g each Light Curing Composite
MICERIUM SPA
EHRTBF1
In Commercial Distribution

  • EMICEHRTBF11 ()
  • EMICCOSVITBF10 ()

  • Weight: 3.6 Gram
EHRTBF1

  • Dental composite resin
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