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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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Console iOptima INT 1x MX2 - J00716010740011

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
1601074-001
In Commercial Distribution

  • J00716010740011 ()
1601074-001

  • Surgical power tool system control unit, line-powered

BOARD DMX3 iOPTIMA INT BOX - J00716010150011

Boards are essential accessories meant to drive electrical micro-motors
Bien-Air Dental SA
1601015-001
In Commercial Distribution

  • J00716010150011 ()
1601015-001

  • Surgical power tool system control unit, line-powered

Board FO890 - J00716001420011

Boards are essential accessories meant to drive electrical micro-motors
Bien-Air Dental SA
1600142-001
In Commercial Distribution

  • J00716001420011 ()
1600142-001

  • Surgical power tool system control unit, line-powered

S2 Mini Drill - J00754521000001

No Description
Bien-Air Surgery SA
1600980
Not in Commercial Distribution

  • J00754521000000 ()
  • J00754521000001 ()
1600980-001

  • Surgical power tool system control unit, line-powered

SET OPTIMA MX2 EDUCATIONAL 6 - J007170081701

Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit.
Bien-Air Dental SA
1700817-0
In Commercial Distribution

  • J007170081701 ()
1700817-0

  • Surgical power tool system control unit, line-powered

SET OPTIMA MX2 EDUCATIONAL 6 - J00717008170011

Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit.
Bien-Air Dental SA
1700817-001
In Commercial Distribution

  • J00717008170011 ()
1700817-001

  • Surgical power tool system control unit, line-powered

Set OSSEODOC + BASCH-1 - J00717005410011

No Description
Bien-Air Surgery SA
1700541
Not in Commercial Distribution

  • J00717005410011 ()
1700541-001

  • Surgical power tool system control unit, line-powered

Set OSSEODOC + BASCH-1 + Pump - J00717005250011

No Description
Bien-Air Surgery SA
1700525
Not in Commercial Distribution

  • J00717005250011 ()
1700525-001

  • Surgical power tool system control unit, line-powered

Set OSSEODUO + NANO - J00717005240011

No Description
Bien-Air Surgery SA
1700524
Not in Commercial Distribution

  • J00717005240011 ()
1700524-001

  • Surgical power tool system control unit, line-powered

Set OSSEODUO + RAPIDO - J00717005230011

No Description
Bien-Air Surgery SA
1700523
Not in Commercial Distribution

  • J00717005230011 ()
1700523-001

  • Surgical power tool system control unit, line-powered
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