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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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VECTOR MICROLite Super Mini Prophy Handpiece
Vector R&D, Inc.
ML500
In Commercial Distribution

  • 00810113690315 ()
ML500

  • Dental delivery system instrument unit, pneumatic
A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.
Flight Dental Systems
A6EP-102
In Commercial Distribution

  • D884A6EP1020 ()
A6 Radius Package

  • Dental delivery system instrument unit, pneumatic
A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.
Flight Dental Systems
A6EP-100
In Commercial Distribution

  • D884A6EP1000 ()
A6 Standard Operatory Package

  • Dental delivery system instrument unit, pneumatic
The A12 Operatory Package is a hydraulic dental chair with a radius swing mount delivery system. The dental chair features an ergonomic back and seat with synchronized movement. The chair also has the ability to rotate 30 degrees to the left and right.
Flight Dental Systems
A12H-100
In Commercial Distribution

  • D884A12HP1000 ()
A12 Operatory Package

  • Dental delivery system instrument unit, pneumatic
A stationary assembly of mains electricity (AC-powered) devices intended to produce two or three-dimensional (3-D) diagnostic digital x-ray images of a patient’s breast using cone beam computed tomography (CBCT); it may be intended to assist a breast biopsy procedure by providing 3-D localization and guidance. It consists of an x-ray source assembly and flat panel X-ray detector (gantry), high-frequency generator, and operating console with reconstruction software; it typically includes a patient table/platform with a hole through which the breast is inserted and scanned.
KONING CORPORATION
CBCT 1000
In Commercial Distribution

  • 19764496368300 ()
CBCT 1000

  • Cone beam computed tomography system, mammographic
Advanced Air Controller A-dec
W & H Dentalwerk Bürmoos GmbH
30223001
Not in Commercial Distribution

  • J021302230011 ()


  • Dental delivery system instrument unit, pneumatic
Electronic for Advanced Air
W & H Dentalwerk Bürmoos GmbH
30223000
In Commercial Distribution

  • J021302230001 ()


  • Dental delivery system instrument unit, pneumatic
Rear Mount on Chair w/Cuspidor, Series 5
DCI International, LLC
RM5
In Commercial Distribution

  • 00810021439280 ()
RM5C

  • Dental delivery system instrument unit, pneumatic
Rear Mount International, Prep for Canttani
DCI International, LLC
RM5
In Commercial Distribution

  • 00810021439273 ()
RM5553

  • Dental delivery system instrument unit, pneumatic
Rear Mount International, Prep for Durr
DCI International, LLC
RM5
In Commercial Distribution

  • 00810021439266 ()
RM5552

  • Dental delivery system instrument unit, pneumatic
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