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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 Chiropro L + CA 20:1 L - J00717003070011

Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700307-001
In Commercial Distribution

  • J00717003070011 ()
1700307-001

  • 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 - 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

Console Chiropro 3rd Gen. - J00716009950011

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1600995-001
In Commercial Distribution

  • J00716009950011 ()
1600995-001

  • Surgical power tool system control unit, line-powered

NA - 10886982128188

STANDARD CONSOLE-W/IRRIGATION W/O TORQUE-LIMITING-F/EPD
Synthes GmbH
05.001.006
In Commercial Distribution

  • H679050010060 ()
  • 10886982128188 ()
05001006

  • Surgical power tool system control unit, line-powered

NA - 10886982128164

BASIC CONSOLE FOR ELECTRIC PEN DRIVE
Synthes GmbH
05.001.002
In Commercial Distribution

  • 07611819167704 ()
  • H679050010020 ()
  • 10886982128164 ()
05001002

  • Surgical power tool system control unit, line-powered
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