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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) - 08809458310240

Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA55R50
In Commercial Distribution

  • 08809458310240 ()
  • 18809458310247 ()

  • Height: 2 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Length: 12.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310233

Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA55R40
In Commercial Distribution

  • 08809458310233 ()
  • 18809458310230 ()

  • Height: 2 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Length: 11.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310226

Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA55R30
In Commercial Distribution

  • 08809458310226 ()
  • 18809458310223 ()

  • Height: 2 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Length: 10.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310219

Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA55R20
In Commercial Distribution

  • 08809458310219 ()
  • 18809458310216 ()

  • Height: 2 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Length: 9.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310202

Screw Abutment Ø5.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA55R10
In Commercial Distribution

  • 08809458310202 ()
  • 18809458310209 ()

  • Height: 2 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Length: 8.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310196

Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA45R40
In Commercial Distribution

  • 08809458310196 ()
  • 18809458310193 ()

  • Height: 2 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Length: 11.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310189

Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA45R30
In Commercial Distribution

  • 08809458310189 ()
  • 18809458310186 ()

  • Height: 2 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Length: 10.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310172

Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA45R20
In Commercial Distribution

  • 08809458310172 ()
  • 18809458310179 ()

  • Height: 2 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Length: 9.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310165

Screw Abutment Ø4.5 RP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA45R10
In Commercial Distribution

  • 08809458310165 ()
  • 18809458310162 ()

  • Height: 2 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Length: 8.97 Millimeter


  • Dental implant suprastructure, permanent, preformed

SIS (Luna) - 08809458310158

Screw Abutment Ø4.5 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy 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.
SSA45N40
In Commercial Distribution

  • 08809458310158 ()
  • 18809458310155 ()

  • Height: 2 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Length: 11.2 Millimeter


  • Dental implant suprastructure, permanent, preformed
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