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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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Tur Bora LK - J00716007320011

Turbines are intended to generate rotating mechanical energy from compressed air
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
1600732-001
In Commercial Distribution

  • J00716007320011 ()
1600732-001

  • Dental power tool system handpiece, pneumatic

TUR BORA LK BLACKLINE - J00716007310011

Turbines are intended to generate rotating mechanical energy from compressed air
Bien-Air Dental SA
1600731-001
In Commercial Distribution

  • J00716007310011 ()
1600731-001

  • Dental power tool system handpiece, pneumatic

CONSOLE PROIMPLANT - J00716007300011

Proimplant is an electrical medical device used to run dental instruments
Bien-Air Dental SA
1600730-001
In Commercial Distribution

  • J00716007300011 ()
1600730-001

  • Surgical power tool system control unit, line-powered

CONSOLE CHIROPRO - J00716007240011

Chiropro are electrical medical devices used to run dental instruments
Bien-Air Dental SA
1600724-001
In Commercial Distribution

  • J00716007240011 ()
1600724-001

  • Surgical power tool system control unit, line-powered

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

Hose MX2 400 Grey - J00716007000011

Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
1600700-001
In Commercial Distribution

  • J00716007000011 ()
1600700-001

  • Pneumatic dental handpiece coupler

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

HOSE 4VX SURF6 ADEC - J00716006950011

Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
1600695-001
In Commercial Distribution

  • J00716006950011 ()
1600695-001

  • Pneumatic dental power tool hose

PM 1:1 Micro-Series - J00716006930011

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
1600693-001
In Commercial Distribution

  • J00716006930011 ()
1600693-001

  • Dental power tool system handpiece, remotely-driven
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