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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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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

CONSOLE OPTIMA MX INT - J00716005340011

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
1600534-001
In Commercial Distribution

  • J00716005340011 ()
1600534-001

  • Surgical power tool system control unit, line-powered

OSSEODUO Control Unit - J00716005130011

No Description
Bien-Air Surgery SA
1600513
Not in Commercial Distribution

  • J00716005130011 ()
1600513-001

  • Surgical power tool system control unit, line-powered

Chiropro 980 4 Buttons Foot Control - J00716003910011

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1600391-001
In Commercial Distribution

  • J00716003910011 ()
1600391-001

  • Surgical power tool system control unit, line-powered

BOARD MPPEO21 FO - J00716003500011

Boards are essential accessories meant to drive electrical micro-motors
Bien-Air Dental SA
1600350-001
In Commercial Distribution

  • J00716003500011 ()
1600350-001

  • Surgical power tool system control unit, line-powered

iOptima/Optima support bracket for installation under dental unit - J00715020560011

Accessory for installation under dental unit
Bien-Air Dental SA
1502056-001
In Commercial Distribution

  • J00715020560011 ()
1502056-001

  • Surgical power tool system control unit, line-powered

iOptima/Optima support bracket for installation beside dental unit - J00715019880011

Accessory for installation beside dental unit
Bien-Air Dental SA
1501988-001
In Commercial Distribution

  • J00715019880011 ()
1501988-001

  • Surgical power tool system control unit, line-powered
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