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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 Small (0.3 – 1.0 mm) 1.0 cc
In Commercial Distribution

  • 10810051880059 ()
HA90D10S

  • 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 Small (0.3 – 1.0 mm) 0.5 cc
In Commercial Distribution

  • 10810051880042 ()
HA90D05S

  • 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) 1.0 cc
In Commercial Distribution

  • 10810051880028 ()
HA90D10L

  • 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 Small (0.3 – 1.0 mm) 2.0 cc
In Commercial Distribution

  • 10810051880080 ()
HA90D20S

  • 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 Small (0.3 – 1.0 mm) 3.0 cc
In Commercial Distribution

  • 10810051880066 ()
HA90D30S

  • 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) 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
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-420
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.5 Milliliter


  • Orbital sphere implant
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-120
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 4 Milliliter


  • Orbital sphere implant
R-GENIN is a bone void filler consisting of purified bovine collagen, hydroxyapatite, tri-calcium phosphate, and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone. R-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.
BERKELEY ADVANCED BIOMATERIALS, LLC
RGT-100X25-10
In Commercial Distribution

  • 00816125022311 ()
RGT-100X25-10

  • Cadaveric-donor/synthetic mineral bone graft
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