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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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Dental Instrument - 08809471725335

No Description
Cowellmedi Co.,Ltd
2KHDS01S
In Commercial Distribution

  • 08809471725335 ()


  • Surgical screwdriver, reusable

Dental Instrument - 08809471725328

No Description
Cowellmedi Co.,Ltd
2KMMS01X
In Commercial Distribution

  • 08809471725328 ()


  • Surgical screwdriver, reusable

Sub. Hex. Machine Fixture Driver - 08809471725311

No Description
Cowellmedi Co.,Ltd
2KMMS01L
In Commercial Distribution

  • 08809471725311 ()


  • Dental implant/prosthesis surgical procedure kit

Sub. Hex. Machine Fixture Driver - 08809471725304

No Description
Cowellmedi Co.,Ltd
2KMMS01S
In Commercial Distribution

  • 08809471725304 ()


  • Dental implant/prosthesis surgical procedure kit

SI - 08809458315771

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 In case of Mount type, it is connected with implant in package and the upper part of the Mount is connected with Mount Driver in implantation.
Shinhung MST Co., Ltd.
SMAR01
In Commercial Distribution

  • 08809458315771 ()
  • 18809458315778 ()

  • Outer Diameter: 3.7 Millimeter
  • Length: 14.5 Millimeter


  • Dental implant suprastructure kit

SI - 08809458315726

Mount 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 In case of Mount type, it is connected with implant in package and the upper part of the Mount is connected with Mount Driver in implantation.
Shinhung MST Co., Ltd.
SMAN01
In Commercial Distribution

  • 08809458315726 ()
  • 18809458315723 ()

  • Outer Diameter: 3.6 Millimeter
  • Length: 15.2 Millimeter


  • Dental implant suprastructure kit

EQ-V - 08809455600559

Seal driver
META SYSTEMS CO., LTD.
EQV-F25
Not in Commercial Distribution

  • 08809455600559 ()


  • Endodontic obturation system

Tools-Screws - 00842188130205

Torx 8 Driver, 180mm AO Breakaway
Trimed, INC.
DVTX-8/180 AO B
In Commercial Distribution

  • 00842188130205 ()
DVTX-8/180 AO B

  • Surgical screwdriver, reusable

Tools-Screws - 00842188130199

Torx 8 Driver, 110mm AO Breakaway
Trimed, INC.
DVTX-8/110 AO B
In Commercial Distribution

  • 00842188130199 ()
DVTX-8/110 AO B

  • Surgical screwdriver, reusable

Drills - 00842188128752

Drill 1.5, 95mm Cannulated
Trimed, INC.
DRILL-1.5/095C
In Commercial Distribution

  • 00842188128752 ()
DRILL-1.5/095C

  • Cannulated surgical drill bit, single-use
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