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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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InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic for bone regeneration. It is comprised of 90% ± 5% hydroxyapatite (HA) and 10% ± 5% Beta-Tricalcium Phosphate. The granules are provided sterile (gamma irradiated) in a capped vial packaged in a lid sealed tray. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, secondary channel-like structure, and tertiary small holes on the surface in a biocompatible and osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental SBG is available in granule form in sizes of 0.3 – 1.0 mm (Small) and 0.8 – 1.8 mm (Large).
Osteogene Tech Corp
HA90D Large (0.8 – 1.8 mm) 3.0 cc
In Commercial Distribution

  • 10810051880035 ()
HA90D30L

  • Synthetic bone graft
InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic for bone regeneration. It is comprised of 90% ± 5% hydroxyapatite (HA) and 10% ± 5% Beta-Tricalcium Phosphate. The granules are provided sterile (gamma irradiated) in a capped vial packaged in a lid sealed tray. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, secondary channel-like structure, and tertiary small holes on the surface in a biocompatible and osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental SBG is available in granule form in sizes of 0.3 – 1.0 mm (Small) and 0.8 – 1.8 mm (Large).
Osteogene Tech Corp
HA90D Large (0.8 – 1.8 mm) 0.5 cc
In Commercial Distribution

  • 10810051880011 ()
HA90D05L

  • Synthetic bone graft
Resorbable Bone Graft Substitute Block, W-Block
Biomet Orthopedics, LLC
5RBW180
In Commercial Distribution

  • 00888480584940 ()

  • 22 mm X 25 mm X 60 mm Block (18.0 cc)
5RBW180

  • Bone matrix implant, synthetic, non-antimicrobial
Resorbable Bone Graft Substitute Block, W-Block
Biomet Orthopedics, LLC
5RBW166
In Commercial Distribution

  • 00888480584933 ()

  • 20 mm X 25 mm X 60 mm Block (16.6 cc)
5RBW166

  • Bone matrix implant, synthetic, non-antimicrobial
Resorbable Bone Graft Substitute Block, W-Block
Biomet Orthopedics, LLC
5RBW144
In Commercial Distribution

  • 00888480584926 ()

  • 17 mm X 25 mm X 60 mm Block (14.4 cc)
5RBW144

  • Bone matrix implant, synthetic, non-antimicrobial
Resorbable Bone Graft Substitute Block, W-Block
Biomet Orthopedics, LLC
5RBW130
In Commercial Distribution

  • 00888480584919 ()

  • 15 mm X 25 mm X 60 mm Block (13.0 cc)
5RBW130

  • Bone matrix implant, synthetic, non-antimicrobial
Resorbable Bone Graft Substitute Block, W-Block
Biomet Orthopedics, LLC
5RBW101
In Commercial Distribution

  • 00888480584896 ()

  • 11 mm X 25 mm X 60 mm Block (10.1 cc)
5RBW101

  • Bone matrix implant, synthetic, non-antimicrobial
Resorbable Bone Graft Substitute Block, W-Block
Biomet Orthopedics, LLC
5RBW079
In Commercial Distribution

  • 00888480584872 ()

  • 8 mm X 25 mm X 60 mm Block (7.9 cc)
5RBW079

  • Bone matrix implant, synthetic, non-antimicrobial
Resorbable Bone Graft Substitute - Block
Biomet Orthopedics, LLC
5RB100
In Commercial Distribution

  • 00888480584742 ()

  • 12 mm x 25 mm x 25 mm Block (7.5 cc)
5RB100

  • Bone matrix implant, synthetic, non-antimicrobial
Resorbable Bone Graft Substitute - Block
Biomet Orthopedics, LLC
5RB040
In Commercial Distribution

  • 00888480584711 ()

  • 10 mm x 10 mm x 40 mm Block (4.0 cc)
5RB040

  • Bone matrix implant, synthetic, non-antimicrobial
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