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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 OSSEOSTAP + Control Unit - J00717003310011

No Description
Bien-Air Surgery SA
1700331
In Commercial Distribution

  • J00717003310011 ()
1700331-001

  • 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 iOptima INT MX2 MX-i - J00716010760011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601076-001
In Commercial Distribution

  • J00716010760011 ()
1601076-001

  • Surgical power tool system control unit, line-powered

Console iOptima INT 2x MX2 - J00716010750011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601075-001
In Commercial Distribution

  • J00716010750011 ()
1601075-001

  • Surgical power tool system control unit, line-powered
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