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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Cabinet Mounted Assistant's Instrumentation Premium 3 Position Precision Comfort (Syr, HVE, SE)
DCI International, LLC
5416
In Commercial Distribution

  • 00810021434339 ()


  • Dental delivery system instrument unit, pneumatic
Wall & Cabinet Mounted Assistants Instrumentation Premium 3 Position Precision Comfort (2 HVE, SE)
DCI International, LLC
5415
In Commercial Distribution

  • 00810021434322 ()


  • Dental delivery system instrument unit, pneumatic
Wall & Cabinet Mounted Assistants Instrumentation Standard 3 Position
DCI International, LLC
5414
In Commercial Distribution

  • 00810021434315 ()


  • Dental delivery system instrument unit, pneumatic
Wall & Cabinet Mounted Assistants Instrumentation Standard 4 Position
DCI International, LLC
5413
In Commercial Distribution

  • 00810021434308 ()


  • Dental delivery system instrument unit, pneumatic
Wall & Cabinet Mounted Assistants Instrumentation Standard 3 Position (2 HVE, SE)
DCI International, LLC
5412
In Commercial Distribution

  • 00810021434292 ()


  • Dental delivery system instrument unit, pneumatic
Wall & Cabinet Mounted Assistants Instrumentation Economy 4 Position (Syr, 2 HVE, SE)
DCI International, LLC
5409
In Commercial Distribution

  • 00810021434285 ()


  • Dental delivery system instrument unit, pneumatic
Wall & Cabinet Mounted Assistants Instrumentation Economy 3 Position (2 HVE, SE)
DCI International, LLC
5404
In Commercial Distribution

  • 00810021434261 ()


  • Dental delivery system instrument unit, pneumatic
Precision Comfort Vacuum Package, 2 HVE, SE, w/Sterling Tubing
DCI International, LLC
5382
In Commercial Distribution

  • 00810021434254 ()


  • Dental delivery system instrument unit, pneumatic
Economy Assistant's Package, HVE, SE, SYR
DCI International, LLC
5369
In Commercial Distribution

  • 00810021434216 ()
C5552

  • Dental delivery system instrument unit, pneumatic
Precision Comfort Vacuum Package, 2 HVE, SE
DCI International, LLC
5365
In Commercial Distribution

  • 00810021434186 ()


  • 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 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
Safco Incite 20,000 rpm low speed motor only
SAFCO DENTAL SUPPLY CO.
1022885
In Commercial Distribution

  • 00810063750541 ()
1022885

  • Dental delivery system instrument unit, pneumatic
Safco Incite low speed motor set
SAFCO DENTAL SUPPLY CO.
1022883
In Commercial Distribution

  • 00810063750534 ()
1022883

  • Dental delivery system instrument unit, pneumatic
SpaceFile® Air Motor
DENTSPLY SIRONA ORTHODONTICS INC.
40027MOT
Not in Commercial Distribution

  • D74640027MOT1 ()
40027MOT

  • Dental delivery system instrument unit, pneumatic
SpaceFile® Contra-angle Handpiece
DENTSPLY SIRONA ORTHODONTICS INC.
40027ANG
Not in Commercial Distribution

  • D74640027ANG1 ()
40027ANG

  • Dental delivery system instrument unit, pneumatic
1340/3 Mob Tableside Control Pedestal(7.7x25mm section)
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3
In Commercial Distribution

  • 05055449415750 ()
1340/3

  • Radiation shielding panel, portable/mobile
1340/3/LR Mob Tableside Control Pedestal (7.7x25mmSect) & shield
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3/LR
In Commercial Distribution

  • 05055449415743 ()
1340/3/LR

  • Radiation shielding panel, portable/mobile
1340/3/10/LR Mob Tableside Control Pedestal (10x25mmSect) & shield
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3/10/LR
In Commercial Distribution

  • 05055449415675 ()
1340/3/10/LR

  • Radiation shielding panel, portable/mobile
1340/3/10 Mob Tableside Control Pedestal(10x25mm section)
KENEX (ELECTRO-MEDICAL) LIMITED
1340/3/10
In Commercial Distribution

  • 05055449415668 ()
1340/3/10

  • Radiation shielding panel, portable/mobile
Shield 310/B-3 With 769x10x25mm Rail
KENEX (ELECTRO-MEDICAL) LIMITED
310/B-3/31
In Commercial Distribution

  • 05055449402682 ()
310/B-3/31

  • Radiation shielding panel, portable/mobile
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