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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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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
1600632-001
In Commercial Distribution

  • J00716006320011 ()
1600632-001

  • Dental power tool system handpiece, remotely-driven
Used to control the console used in dentistry for implantology, dental surgery and endodontic work.
Bien-Air Dental SA
1600631-001
In Commercial Distribution

  • J00716006310011 ()
1600631-001

  • Foot-switch, electrical
  • Surgical power tool system control unit, line-powered
No Description
Bien-Air Surgery SA
1600629
Not in Commercial Distribution

  • J00716006290 ()
  • J00716006290011 ()
1600629-001

  • Electrical-only medical device connection cable, reusable
No Description
Bien-Air Surgery SA
1600628
Not in Commercial Distribution

  • J00716006280011 ()
1600628-001

  • Surgical power tool system control unit, line-powered
Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments
Bien-Air Dental SA
1600617-001
In Commercial Distribution

  • J00716006170011 ()
  • J00716006170061 ()
1600617-001

  • Surgical instrument maintenance lubricant
No Description
Bien-Air Surgery SA
1600614
Not in Commercial Distribution

  • J00716006140 ()
  • J00716006140011 ()
1600614-001

  • ENT shaver system handpiece
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
No Description
Bien-Air Surgery SA
1600612
Not in Commercial Distribution

  • J00716006120 ()
  • J00716006120011 ()
1600612-001

  • Drilling power tool attachment, basic
Accessory connects micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
1600606-001
In Commercial Distribution

  • J00716006060011 ()
1600606-001

  • Dental power tool handpiece motorless component
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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