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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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AZENA MEDICAL, LLC
8990
Not in Commercial Distribution

  • 00861407000389 ()


  • Dental diode laser system
A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Biolase, Inc.
7400055 Refurbished
In Commercial Distribution

  • 00647529002599 ()


  • Musculoskeletal/physical therapy laser, professional
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054 Refurbished
In Commercial Distribution

  • 00647529002575 ()


  • General/multiple surgical diode laser system
A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Biolase, Inc.
7400055
In Commercial Distribution

  • 00647529000267 ()
7400055

  • Musculoskeletal/physical therapy laser, professional
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054
In Commercial Distribution

  • 00647529000236 ()
7400054

  • General/multiple surgical diode laser system
Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420
Not in Commercial Distribution

  • D74666614201 ()
6661420

  • Dental diode laser system
Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556
Not in Commercial Distribution

  • D74666595561 ()
6659556

  • Dental diode laser system
MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309
Not in Commercial Distribution

  • D74666593091 ()
6659309

  • Dental diode laser system
EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291
Not in Commercial Distribution

  • D74666592911 ()
  • D74666592910 ()
6659291

  • Dental diode laser system
EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283
Not in Commercial Distribution

  • D74666592831 ()
  • D74666592830 ()
6659283

  • Dental diode laser system
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