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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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Lubricare 2 is intended for lubricating and cleaning the inside of dental instruments.
Bien-Air Dental SA
1601156-001
In Commercial Distribution

  • J00716011560011 ()
1601156-001

  • Surgical instrument maintenance lubricant
  • Dental handpiece maintenance unit
Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light.
Bien-Air Dental SA
1601153-001
In Commercial Distribution

  • J00716011530011 ()
1601153-001

  • Dental power tool system handpiece, pneumatic
Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light.
Bien-Air Dental SA
1601152-001
In Commercial Distribution

  • J00716011520011 ()
1601152-001

  • Dental power tool system handpiece, pneumatic
Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1601147-001E
In Commercial Distribution

  • J0071601147001E1 ()


  • Surgical power tool system control unit, line-powered
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
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed.
Bien-Air Dental SA
1601139-001
In Commercial Distribution

  • J00716011390011 ()
1601139-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601138-0
In Commercial Distribution

  • J007160113801 ()
1601138-0

  • Dental laboratory drilling system handpiece
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed.
Bien-Air Dental SA
1601138-001
In Commercial Distribution

  • J00716011380011 ()
1601138-001

  • Dental power tool system handpiece, remotely-driven
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed
Bien-Air Dental SA
1601137-001
In Commercial Distribution

  • J00716011370011 ()
1601137-001

  • Dental power tool system handpiece, remotely-driven
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed
Bien-Air Dental SA
1601136-001
In Commercial Distribution

  • J00716011360011 ()
1601136-001

  • Dental power tool system handpiece, remotely-driven
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