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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 iOptima without Motor - J00717005470011

Sets of iOptima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700547-001
In Commercial Distribution

  • J00717005470011 ()
1700547-001

  • Surgical power tool system control unit, line-powered

Set Optima MX2 INT PRO + B24-32V - J00717005460011

Sets of Optima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700546-001
In Commercial Distribution

  • J00717005460011 ()
1700546-001

  • Surgical power tool system control unit, line-powered

Optima MX2 INT PRO - J00717005450011

Sets of Optima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700545-001
In Commercial Distribution

  • J00717005450011 ()
1700545-001

  • Surgical power tool system control unit, line-powered

Set iOptima - J00717005440011

Sets of iOptima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700544-001
In Commercial Distribution

  • J00717005440011 ()
1700544-001

  • 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 Optima INT PRO / 100586 - J00717005400011

Sets of Optima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700540-001
In Commercial Distribution

  • J00717005400011 ()
1700540-001

  • 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

Set OSSEODUO + S120 + NANO - J00717005220011

No Description
Bien-Air Surgery SA
1700522
Not in Commercial Distribution

  • J00717005220011 ()
1700522-001

  • Surgical power tool system control unit, line-powered
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