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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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Set Chiropro L - J00717002980011

Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700298-001
In Commercial Distribution

  • J00717002980011 ()
1700298-001

  • Surgical power tool system control unit, line-powered

Set OSSEODUO + 80K - J00717002510011

No Description
Bien-Air Surgery SA
1700251
Not in Commercial Distribution

  • J00717002510011 ()
1700251-001

  • Surgical power tool system control unit, line-powered

Set OSSEODUO + S120 - J00717002500011

No Description
Bien-Air Surgery SA
1700250
Not in Commercial Distribution

  • J00717002500011 ()
1700250-001

  • Surgical power tool system control unit, line-powered

Set OSSEODUO + S120 + 80K - J00717002490011

No Description
Bien-Air Surgery SA
1700249
Not in Commercial Distribution

  • J00717002490011 ()
1700249-001

  • Surgical power tool system control unit, line-powered

Set OSSEODOC + BASCH - J00717001690011

No Description
Bien-Air Surgery SA
1700169
In Commercial Distribution

  • J00717001690011 ()
1700169-001

  • Surgical power tool system control unit, line-powered

Set OSSEODOC + BASCH + Pump - J00717001680011

No Description
Bien-Air Surgery SA
1700168
Not in Commercial Distribution

  • J00717001680011 ()
1700168-001

  • Surgical power tool system control unit, line-powered

BASCH Micromotor + Cable - J00717000740011

No Description
Bien-Air Surgery SA
1700074
In Commercial Distribution

  • J00717000740011 ()
1700074-001

  • Surgical power tool system control unit, line-powered

IDUP board - J00716011960051

integrable devices are electronic boards that allow the control of Bien-Air Electric micromotors as well as various dental instruments. They are intended to be integrated into a dental unit (kart or dental chair). iOPTIMA INT and Integrated Dental Unit Platform (IDUP) are dental chair’s integrated device allowing the control of dental and surgical micromotors parameters (such as torque, speed, and direction of rotation), irrigation pump and dental accessories via a user interface. For iOptima INT devices, the user interface is and Apple Device.
Bien-Air Dental SA
1601196-005
In Commercial Distribution

  • J00716011960051 ()


  • Surgical power tool system control unit, line-powered

CONSOLE BIOPOWER - J0071601147001E1

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1601147-001E
In Commercial Distribution

  • J0071601147001E1 ()


  • Surgical power tool system control unit, line-powered

CONSOLE BIOPOWER - J00716011470011

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1601147-001
In Commercial Distribution

  • J00716011470011 ()
1601147-001

  • Surgical power tool system control unit, line-powered
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