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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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SIS (Luna) - 08809457200580

Luna Ø4.0 x 10 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function
Shinhung MST Co., Ltd.
SIR4010S
In Commercial Distribution

  • 08809457200580 ()
  • 18809457200587 ()

  • Outer Diameter: 4.2 Millimeter
  • Length: 10 Millimeter


  • Screw endosteal dental implant, two-piece

SIS (Luna) - 08809457200573

Luna Ø4.0 x 8.5 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function
Shinhung MST Co., Ltd.
SIR4008S
In Commercial Distribution

  • 08809457200573 ()
  • 18809457200570 ()

  • Outer Diameter: 4.2 Millimeter
  • Length: 8.5 Millimeter


  • Screw endosteal dental implant, two-piece

SI - 08809457200610

Luna Ø4.0 x 15 mm RP S&E Mount The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy(ISO22674) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function
Shinhung MST Co., Ltd.
SIR4015S
In Commercial Distribution

  • 08809457200610 ()
  • 18809457200617 ()

  • Outer Diameter: 4.2 Millimeter
  • Length: 15 Millimeter


  • Screw endosteal dental implant, two-piece
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