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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AS-1 Dr's dual purpose cart with table top (Dr's and assistant's)
Engle Dental Systems, LLC
P050135
In Commercial Distribution

  • 00850043433125 ()
P050135

  • Dental delivery system instrument unit, pneumatic
Assistant's cart with upper tier, table top, and keyboard tray
Engle Dental Systems, LLC
P050330
In Commercial Distribution

  • 00850043433101 ()
P050330

  • Dental delivery system instrument unit, pneumatic
E300 Dr's dual purpose cart with upper tier, table top, and keyboard tray (Dr's and assistant's)
Engle Dental Systems, LLC
P050320
In Commercial Distribution

  • 00850043433095 ()
P050320

  • Dental delivery system instrument unit, pneumatic
E300 Dr's dual purpose cart with upper tier and table top (Dr's and assistant's)
Engle Dental Systems, LLC
P050310
In Commercial Distribution

  • 00850043433088 ()
P050310

  • Dental delivery system instrument unit, pneumatic
E300 Dr's dual purpose cart with table top (Dr's and assistant's)
Engle Dental Systems, LLC
P050300
In Commercial Distribution

  • 00850043433071 ()
P050300

  • Dental delivery system instrument unit, pneumatic
Ultrapro Tx Air Blue Nose Cone Kit
ULTRADENT PRODUCTS, INC.
8505-
In Commercial Distribution

  • 00883205028068 ()
  • 00883205033369 ()
8505-

  • Dental delivery system instrument unit, pneumatic
Ultrapro Tx Air Pink Nose Cone Kit
ULTRADENT PRODUCTS, INC.
8504-
In Commercial Distribution

  • 00883205028051 ()
  • 00883205033352 ()
8504-

  • Dental delivery system instrument unit, pneumatic
Ultrapro Tx Air Green Nose Cone Kit
ULTRADENT PRODUCTS, INC.
8503-
In Commercial Distribution

  • 00883205028044 ()
  • 00883205033345 ()
8503-

  • Dental delivery system instrument unit, pneumatic
Ultrapro Tx Air Motor Kit
ULTRADENT PRODUCTS, INC.
8506-
In Commercial Distribution

  • 00883205028037 ()
  • 00883205033338 ()
8506-

  • Dental delivery system instrument unit, pneumatic
Zoral® System is a Portable Self-Contained Bottle System that dispenses a liquid irrigating ultrasonic solution to a dental scaler during dental hygiene cleaning procedures (ITEM # MAK-1310). Zoral System is attached to the dental unit's quick disconnect air to pressurize the Zoral System.
Anodia Systems
00854542008372
In Commercial Distribution

  • 00854542008211 ()
item # MAK-1310

  • Dental delivery system instrument unit, pneumatic
Dental Control Unit
Biotec Incorporated
Control Unit
In Commercial Distribution

  • 00860011235002 ()


  • Dental delivery system instrument unit, pneumatic
Gator Torque - XTC Motor Only, 5,000rpm Midwest style connection
Vector R&D, Inc.
GT-XTC
In Commercial Distribution

  • 00810113691008 ()
GT-XTC

  • Dental delivery system instrument unit, pneumatic
VECTOR Air Motor with internal spray
Vector R&D, Inc.
AM1011
In Commercial Distribution

  • 00810113690872 ()
AM1011

  • Dental delivery system instrument unit, pneumatic
TURBO TORQUE Reciprocating Endo Set (Motor & 10:1 red angle W/ hand file TEP-Y head)
Vector R&D, Inc.
TT-20KTEP
In Commercial Distribution

  • 00810113690391 ()
TT-20KTEP

  • Dental delivery system instrument unit, pneumatic
TURBO TORQUE Rotary Endo Set (64:1 Reduction) (Motor & 64:1 red angle w mini latch)
Vector R&D, Inc.
TT-20KRT
In Commercial Distribution

  • 00810113690384 ()
TT-20KRT

  • Dental delivery system instrument unit, pneumatic
TURBO TORQUE Lowspeed 2 OP set up PACKAGE (2-Motors, 2 Nosecones, 5 Contra Angles)
Vector R&D, Inc.
TT-20K-OP
In Commercial Distribution

  • 00810113690377 ()
TT-20K-OP

  • Dental delivery system instrument unit, pneumatic
TURBO TORQUE Lowspeed Motor set, Motor, Straight & Contra Angle
Vector R&D, Inc.
TT-20K
In Commercial Distribution

  • 00810113690360 ()
TT-20K

  • Dental delivery system instrument unit, pneumatic
TURBO TORQUE Lowspeed Motor Only (20,000rpm)
Vector R&D, Inc.
TT-20KM
In Commercial Distribution

  • 00810113690346 ()
TT-20KM

  • Dental delivery system instrument unit, pneumatic
ERGOTorque II, 5,000 RPM lowspeed motor, with swivel nosecone, 4 hole
Vector R&D, Inc.
LMM-4
In Commercial Distribution

  • 00810113690339 ()
LMM-4

  • Dental delivery system instrument unit, pneumatic
VECTOR MICROLite XL Mini Prophy Handpiece - Long Neck
Vector R&D, Inc.
ML750
In Commercial Distribution

  • 00810113690322 ()
ML750

  • Dental delivery system instrument unit, pneumatic
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
Rear Mount Assistant's Package, 1 Syringe, 1 HVE & 1 SE
DCI International, LLC
RM5
In Commercial Distribution

  • 00810021439259 ()
RM5551

  • Dental delivery system instrument unit, pneumatic
Rear Mount Assistant's Pkg.
DCI International, LLC
RM5
In Commercial Distribution

  • 00810021439242 ()
RM5152

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

  • 00810021439235 ()
RM5

  • Dental delivery system instrument unit, pneumatic
Rear Mount on Chair w/Cuspidor and Assistants Arm, Series 4
DCI International, LLC
RM4
In Commercial Distribution

  • 00810021439228 ()
RM4CA

  • Dental delivery system instrument unit, pneumatic
Rear Mount on Chair w/Cuspidor, Series 4
DCI International, LLC
RM4
In Commercial Distribution

  • 00810021439211 ()
RM4C

  • Dental delivery system instrument unit, pneumatic
Rear Mount Assistant's Package, 3 HP
DCI International, LLC
RM4
In Commercial Distribution

  • 00810021439204 ()
RM4551

  • Dental delivery system instrument unit, pneumatic
Rear Mount on Chair, Series 4
DCI International, LLC
RM4
In Commercial Distribution

  • 00810021439198 ()
RM4

  • Dental delivery system instrument unit, pneumatic
Reliance Cabinet Mount Manual Control Unit for 2 HP, 2 Wet, w/Asst. Pkg.
DCI International, LLC
4521L
In Commercial Distribution

  • 00810021439181 ()


  • Dental delivery system instrument unit, pneumatic
Reliance Arm Mounted Manual Control Unit for 2HP, 2 Wet w/White Flex Arm
DCI International, LLC
4530
In Commercial Distribution

  • 00810021439174 ()


  • Dental delivery system instrument unit, pneumatic
Reliance Arm Mounted Manual Control Unit for 2HP, 1 Wet & 1 Dry w/White Flex Arm
DCI International, LLC
4529
In Commercial Distribution

  • 00810021439167 ()


  • Dental delivery system instrument unit, pneumatic
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