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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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DESCRIPTION The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied. INDICATION FOR USE The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment Trade Name ATOZ Mini-Screw Consist of MKS-1613*8EA + MKS-1611*2EA
MK Meditech Inc.
MKS-1611 and MKS-1613
In Commercial Distribution

  • 08800197900020 ()


  • Orthodontic anchoring screw
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0331
Not in Commercial Distribution

  • 00851766006085 ()

  • Width: 3 Centimeter
  • Length: 3 Centimeter
  • Height: 1 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0231
Not in Commercial Distribution

  • 00851766006078 ()

  • Width: 2 Centimeter
  • Length: 3 Centimeter
  • Height: 1 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0221
Not in Commercial Distribution

  • 00851766006061 ()

  • Width: 2 Centimeter
  • Length: 2 Centimeter
  • Height: 1 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0405
Not in Commercial Distribution

  • 00851766006054 ()

  • Length: 5 Centimeter
  • Width: 4 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0404
Not in Commercial Distribution

  • 00851766006047 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0304
Not in Commercial Distribution

  • 00851766006030 ()

  • Length: 4 Centimeter
  • Width: 3 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0303
Not in Commercial Distribution

  • 00851766006023 ()

  • Length: 3 Centimeter
  • Width: 3 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0203
Not in Commercial Distribution

  • 00851766006016 ()

  • Width: 2 Centimeter
  • Length: 3 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0202
Not in Commercial Distribution

  • 00851766006009 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter


  • Radiological image marker, implantable
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