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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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Aquasil Ultra XLV (Extra Low Viscosity) 4-Pack Refill Cartridges (Orange)
DENTSPLY INTERNATIONAL INC.
678781
Not in Commercial Distribution

  • D0026787810 ()
  • D0026787811 ()
678781

  • Silicone dental impression material
Aquasil Ultra LV (Low Viscosity) 4-Pack Refill Cartridges (Teal)
DENTSPLY INTERNATIONAL INC.
678779
Not in Commercial Distribution

  • D0026787790 ()
  • D0026787791 ()
678779

  • Silicone dental impression material
Aquasil® Ultra XLV Regular Set Cartridge Refill (Asia Only)
DENTSPLY INTERNATIONAL INC.
678769KR
In Commercial Distribution

  • D002678769KR0 ()
  • D002678769KR1 ()

  • 4 Cartridges (50mL each)
678769KR

  • Silicone dental impression material
Aquasil Ultra+ XLV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678714
In Commercial Distribution

  • D0026787140 ()
  • D0026787141 ()
678714

  • Silicone dental impression material
Aquasil Ultra+ LV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678713
In Commercial Distribution

  • D0026787130 ()
  • D0026787131 ()
678713

  • Silicone dental impression material
Aquasil Ultra+ XLV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678707
In Commercial Distribution

  • D0026787070 ()
  • D0026787071 ()
678707

  • Silicone dental impression material
Aquasil Ultra+ LV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678706
In Commercial Distribution

  • D0026787060 ()
  • D0026787061 ()
678706

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Bulk Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678704
In Commercial Distribution

  • D0026787040 ()
  • D0026787041 ()
678704

  • Silicone dental impression material
Aquasil Ultra+ Tray Material Cartridge Refill, Heavy Extended Set (Green)
DENTSPLY INTERNATIONAL INC.
678703
In Commercial Distribution

  • D0026787030 ()
  • D0026787031 ()
678703

  • Silicone dental impression material
Aquasil Ultra+ XLV Extended Set (Orange)
DENTSPLY INTERNATIONAL INC.
678702
Not in Commercial Distribution

  • D0026787020 ()
  • D0026787021 ()
678702

  • Silicone dental impression material
Aquasil Ultra+ XLV Extended Set 4-Pack Cartridge Refill (Orange)
DENTSPLY INTERNATIONAL INC.
678701
In Commercial Distribution

  • D0026787010 ()
  • D0026787011 ()
678701

  • Silicone dental impression material
Aquasil® Ultra+ Regular Set Kit
DENTSPLY INTERNATIONAL INC.
678699
In Commercial Distribution

  • D0026786990 ()

  • 5 Cartridges (50mL), 12 mix tips, 6 I/O tips; 4 small digit (1.6mL) cartridges, 2 large digit (2.4mL) cartridges, 1 syringe dispenser, 6 digit Mix Tips, 6 I/O tips, 1 bottle adhesive (14mL)
678699

  • Silicone dental impression material
Aquasil Ultra+ digit Power XLV FS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678698
In Commercial Distribution

  • D0026786980 ()
  • D0026786981 ()
678698

  • Silicone dental impression material
Aquasil® Ultra+ Medium Fast Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678697
In Commercial Distribution

  • D0026786973 ()
  • D0026786971 ()
  • D0026786970 ()

  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
  • Total Volume: 380 Milliliter
678697

  • Silicone dental impression material
Aquasil® Ultra+ LV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678642
In Commercial Distribution

  • D0026786421 ()
  • D0026786420 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678642

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678641
In Commercial Distribution

  • D0026786411 ()
  • D0026786410 ()

  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 2.4 Milliliter
678641

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678640
In Commercial Distribution

  • D0026786401 ()
  • D0026786400 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678640

  • Silicone dental impression material
Aquasil Ultra+ Rigid Fast Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678627
In Commercial Distribution

  • D0026786271 ()
  • D0026786270 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678627

  • Silicone dental impression material
Aquasil Ultra+ Heavy Fast Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678626
In Commercial Distribution

  • D0026786261 ()
  • D0026786260 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678626

  • Silicone dental impression material
Aquasil Ultra+ Heavy Regular Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678625
In Commercial Distribution

  • D0026786251 ()
  • D0026786250 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678625

  • Silicone dental impression material
Aquasil Ultra+ Medium Regular Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678602
In Commercial Distribution

  • D0026786021 ()
  • D0026786020 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678602

  • Silicone dental impression material
Aquasil Ultra+ Medium Fast Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678601
In Commercial Distribution

  • D0026786011 ()
  • D0026786010 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678601

  • Silicone dental impression material
Aquasil Ultra LV Fast Set with B4® Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
678450
In Commercial Distribution

  • D00267845082 ()
  • D0026784501 ()
  • D0026784500 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 6 Milliliter
  • 4 cartridges LV FS (50ml), 1 bottle B4 (6ml), 24 Mixing Tips, 24 Intra Oral Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
678450

  • Silicone dental impression material
Aquasil Ultra Heavy FS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678276
In Commercial Distribution

  • D0026782760 ()
  • D0026782761 ()
678276

  • Silicone dental impression material
Aquasil Ultra Heavy RS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678275
In Commercial Distribution

  • D0026782750 ()
  • D0026782751 ()
678275

  • Silicone dental impression material
B4® Pre-Impression Surface Optimizer Refill
DENTSPLY INTERNATIONAL INC.
678132
In Commercial Distribution

  • D0026781320 ()

  • 1 Bottle B4® (6mL), 1 Dispensing Well, 50 Flocked Applicator Tips
678132

  • Silicone dental impression material
Aquasil Ultra Cordless Tissue Managing Impression System Tray (Light Green) 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
678059
In Commercial Distribution

  • D00267805932 ()
  • D0026780591 ()
  • D0026780590 ()

  • 2 DECA™ cartridges, 20 Mixing Tips, 1 Bayonet Ring
  • Total Volume: 380 Milliliter
678059

  • Silicone dental impression material
Aquasil Ultimate Tissue Managing Tray Impression System Cartridge Refill (Light Green)
DENTSPLY INTERNATIONAL INC.
678056
In Commercial Distribution

  • D00267805682 ()
  • D0026780561 ()
  • D0026780560 ()

  • Total Volume: 50 Milliliter
  • 4 (50ml) Cartridges Refill, 12 Mixing Tips (Green)
678056

  • Silicone dental impression material
Aquasil Ultimate digit power® 15 pk Multi Refill with B4
DENTSPLY INTERNATIONAL INC.
678053K
In Commercial Distribution

  • D002678053K1 ()

  • 15 Digit Power Wash Material Cartridges, 15 Digit Power Mixing Tips with Intraoral Tips, 1 Bottle B4 Pre-Impression Surface Optimizer, 1 Dispensing Well, 25 Flocked Applicator Tips
  • Total Volume: 1.6 Milliliter
  • Total Volume: 6 Milliliter
678053K

  • Silicone dental impression material
Aquasil Ultra Cordless Tissue Managing Impression System Wash (Light Blue) w/B4™ digit power Multi 15 (1.60ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678053
In Commercial Distribution

  • D0026780531 ()

  • Total Volume: 6 Milliliter
  • 15 Digit Power Wash Material Cartridges, 15 Digit Power Mixing Tips with Intraoral Tips, 1 Bottle B4™ Pre-Impression Surface Optimizer, 1 Dispensing Well, 25 Flocked Applicator Tips
  • Total Volume: 1.6 Milliliter
678053

  • Silicone dental impression material
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