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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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The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 20A-A
In Commercial Distribution

  • 05712821004840 ()
  • 05712821009234 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 1B-A
In Commercial Distribution

  • 05712821004833 ()
  • 05712821008527 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 1A-B
In Commercial Distribution

  • 05712821004826 ()
  • 05712821008510 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 1A-A
In Commercial Distribution

  • 05712821004819 ()
  • 05712821008503 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4474415000STR0 ()
44-150-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOREVIVE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4474415000REV0 ()
44-150-00-REV

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4474415000BSI0 ()
44-150-00-BSI

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000STR0 ()
44-100-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOREVIVE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000REV0 ()
44-100-00-REV

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOINJECT™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000INJ0 ()
44-100-00-INJ

  • Bone matrix implant, synthetic, non-antimicrobial
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