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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 Class Implantable

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Ti-one 101 - 04719871590010

Dental Implant Ø3.5, 8 mm Length The Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy 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. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.
HUNG CHUN BIO-S CO., LTD.
HF01-103508
In Commercial Distribution

  • 04719871590010 ()


  • Dental implant system

SM3 - 08800000995236

Motor and cord set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Osstem Implant Co., Ltd._Gasan Branch
SL
In Commercial Distribution

  • 08800000995236 ()


  • Dental implant system

SM3 - 08800000995212

SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Osstem Implant Co., Ltd._Gasan Branch
SM3 120V OPT
In Commercial Distribution

  • 08800000995212 ()


  • Dental implant system
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