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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 Optima MX2 INT - J00716007150011

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
1600715-001
In Commercial Distribution

  • J00716007150011 ()
1600715-001

  • Surgical power tool system control unit, line-powered

Chiropro L US - J00716006970011

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1600697-001
In Commercial Distribution

  • J00716006970011 ()
1600697-001

  • Surgical power tool system control unit, line-powered

Board DMX2 Plus - J00716006960011

Boards are essential accessories meant to drive electrical micro-motors
Bien-Air Dental SA
1600696-001
In Commercial Distribution

  • J00716006960011 ()
1600696-001

  • Surgical power tool system control unit, line-powered

OSSEOSTAP Control Unit - J00716006860011

No Description
Bien-Air Surgery SA
1600686
In Commercial Distribution

  • J00716006860011 ()
1600686-001

  • Surgical power tool system control unit, line-powered

OSSEOSTAP + Cable - J00716006850011

No Description
Bien-Air Surgery SA
1600685
Not in Commercial Distribution

  • J00716006850 ()
  • J00716006850011 ()
1600685-001

  • Surgical power tool system control unit, line-powered

CONSOLE CHIROPRO L - J00716006790011

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1600679-001
In Commercial Distribution

  • J00716006790011 ()
1600679-001

  • Surgical power tool system control unit, line-powered

Board DMX2 PRO - J00716006660011

Boards are essential accessories meant to drive electrical micro-motors
Bien-Air Dental SA
1600666-001
In Commercial Distribution

  • J00716006660011 ()
1600666-001

  • Surgical power tool system control unit, line-powered

OSSEOUNO Control Unit - J00716006280011

No Description
Bien-Air Surgery SA
1600628
Not in Commercial Distribution

  • J00716006280011 ()
1600628-001

  • Surgical power tool system control unit, line-powered

Console Chiropro L - J00716006130011

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1600613-001
In Commercial Distribution

  • J00716006130011 ()
1600613-001

  • Surgical power tool system control unit, line-powered

Mot MX LED - J00716006050011

Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
Bien-Air Dental SA
1600605-001
In Commercial Distribution

  • J00716006050011 ()
1600605-001

  • Surgical power tool system control unit, line-powered
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