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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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BIO-C SEALER - 07898078658833

Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER 2 g
Angelus Industria de Produtos Odontologicos S A
BIO-C SEALER 2 g
In Commercial Distribution

  • 07898078658833 ()
3823

  • Endodontic filling/sealing material

BIO-C SEALER - 07898078659816

Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER 0.5 g
Angelus Industria de Produtos Odontologicos S A
BIO-C SEALER 0.5 g
In Commercial Distribution

  • 07898078659816 ()
3822

  • Endodontic filling/sealing material

GC Fuji BOND™ - D0470001791

GC Fuji BOND™LC 5 g powder btl.
Gc America Inc.
000179
In Commercial Distribution

  • D0470001792 ()
  • D0470001791 ()

  • Weight: 5 Gram
000179

  • Dentine adhesive

LINING CEMENT - D0470001091

LINING CEMENT 1-1 Pack (1 x 15 g powder, 1 x 15 g liquid, 1 x scoop, 1 x mixing pad)
Gc America Inc.
000109
In Commercial Distribution

  • D0470001092 ()
  • D0470001091 ()
000109

  • Dental cavity liner

GRADIA® - D0470027951

GRADIA® DIRECT X Syringes - 2.7 mL/5 g X-XBW
Gc America Inc.
002795
In Commercial Distribution

  • D0470027951 ()

  • Total Volume: 2.7 Milliliter
002795

  • Light-cured dental restorative composite resin

GRADIA® - D0470019881

GRADIA® DIRECT Syringes: Anterior - 2.4 mL/4 g A1
Gc America Inc.
001988
In Commercial Distribution

  • D0470019881 ()

  • Total Volume: 2.4 Milliliter
001988

  • Light-cured dental restorative composite resin

Rexious - 08809557204846

Poly Axial screw G type - 12.5x130 housing - 8.5 x 60
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557204846 ()
RG.LR.8560

  • Bone-screw internal spinal fixation system, non-sterile

Rexious - 08809557204839

Poly Axial screw G type - 12.5x130 housing - 8.5 x 55
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557204839 ()
RG.LR.8555

  • Bone-screw internal spinal fixation system, non-sterile

Rexious - 08809557204822

Poly Axial screw G type - 12.5x130 housing - 8.5 x 50
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557204822 ()
RG.LR.8550

  • Bone-screw internal spinal fixation system, non-sterile

Rexious - 08809557204815

Poly Axial screw G type - 12.5x130 housing - 8.5 x 45
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557204815 ()
RG.LR.8545

  • Bone-screw internal spinal fixation system, non-sterile
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