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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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Calibra® Esthetic Resin Cement - D0026070850

Calibra® Esthetic Resin Cement, Dual Cure Automix, Opaque, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607085
In Commercial Distribution

  • D0026070850 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607085

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070840

Calibra® Esthetic Resin Cement, Dual Cure Automix, Translucent, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607084
In Commercial Distribution

  • D0026070840 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607084

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070830

Calibra® Esthetic Resin Cement, Dual Cure Automix, Dark, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607083
In Commercial Distribution

  • D0026070830 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607083

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070820

Calibra® Esthetic Resin Cement, Dual Cure Automix, Medium, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607082
In Commercial Distribution

  • D0026070820 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607082

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070810

Calibra® Esthetic Resin Cement, Dual Cure Automix, Light, 1 (4.5g) syringe Refill
DENTSPLY INTERNATIONAL INC.
607081
In Commercial Distribution

  • D0026070810 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607081

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070800

Calibra® Esthetic Resin Cement, Silane Coupling Agent, 1 (3ml) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607080
In Commercial Distribution

  • D0026070800 ()

  • Total Volume: 3 Milliliter
  • 1 Syringe Calibra® Silane Coupling Agent (3mL) and 25 Applicator Needles
607080

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070690

Calibra® Esthetic Resin Cement, Catalyst, High Viscosity 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607069
In Commercial Distribution

  • D0026070690 ()

  • 1 Syringe Calibra® Catalyst (2g), High Viscosity
  • Weight: 2 Gram
607069

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070680

Calibra® Esthetic Resin Cement, Catalyst, Regular Viscosity, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607068
In Commercial Distribution

  • D0026070680 ()

  • 1 Syringe Calibra® Catalyst (2g), Regular Viscosity
  • Weight: 2 Gram
607068

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070650

Calibra® Esthetic Resin Cement, Base, Opaque, 1 (2g) syringe Refill Page
DENTSPLY INTERNATIONAL INC.
607065
In Commercial Distribution

  • D0026070650 ()

  • Weight: 2 Gram
  • 1 Syringe Calibra® Base Shade (2g), Opaque
607065

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070640

Calibra® Esthetic Resin Cement, Base, Translucent, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607064
In Commercial Distribution

  • D0026070640 ()

  • 1 Syringe Calibra® Base Shade (2g), Translucent
  • Weight: 2 Gram
607064

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070630

Calibra® Esthetic Resin Cement, Base, Dark, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607063
In Commercial Distribution

  • D0026070630 ()

  • 1 Syringe Calibra® Base Shade (2g), Dark
  • Weight: 2 Gram
607063

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070620

Calibra® Esthetic Resin Cement, Base, Medium, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607062
In Commercial Distribution

  • D0026070620 ()

  • 1 Syringe Calibra® Base Shade (2g), Medium
  • Weight: 2 Gram
607062

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070610

Calibra® Esthetic Resin Cement, Base, Light, 1 (2g) syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607061
In Commercial Distribution

  • D0026070610 ()

  • 1 Syringe Calibra® Base Shade (2g), Light
  • Weight: 2 Gram
607061

  • Dental composite resin

Calibra® Esthetic Resin Cement - D0026070571

Calibra® Esthetic Resin Cement Trial Kit
DENTSPLY INTERNATIONAL INC.
607057
In Commercial Distribution

  • D0026070571 ()

  • Weight: 2 Gram
  • 1 Syringe Base Shade Translucent, 1 Syringe Catalyst, 1 Bottle Activator, 1 Bottle Adhesive, and Accessories
607057

  • Dental composite resin

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material - D0026057101

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set Intro Kit Case
DENTSPLY INTERNATIONAL INC.
605710
In Commercial Distribution

  • D0026057101 ()

  • Weight: 454 Gram
  • Case of 9 Canisters Fast Set Intro Kit (454g each) contains: 1 Pouch Jeltrate® Chroma Material (454g), 1 Water Measure, 1 Powder Scoop
605710

  • Alginate dental impression material

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material - D0026057001

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set, Case of 12 pouches
DENTSPLY INTERNATIONAL INC.
605700
In Commercial Distribution

  • D0026057001 ()
  • D0026057000 ()

  • Weight: 454 Gram
  • Case of 12 Pouches Fast Set (454g each)
605700

  • Alginate dental impression material

Silan-IT - 03760260223119

Cross-linking agent containing silan agent to improve adhesion
ITENA CLINICAL
SILAN-IT
In Commercial Distribution

  • 03760260223119 ()


  • Dental prosthesis priming agent

Enamelize™ - EDEL9061010

Enamelize™, Tube 36g
DeltaMed GmbH
906101
In Commercial Distribution

906101

  • Dentifrice

Enamelize™ - EDEL9060000

Enamelize™, Syringe 3g
DeltaMed GmbH
906000
In Commercial Distribution

906000

  • Dentifrice

Renamel® Flowable Microhybrid - EDEL701MWO0

Renamel® Flowable Microhybrid Milky White Occlusal, Syringe 3g
DeltaMed GmbH
701MWO
In Commercial Distribution

701MWO

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL701A350

Renamel® Flowable Microhybrid Body A3.5, Syringe 3g
DeltaMed GmbH
701A35
In Commercial Distribution

701A35

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011MI0

Renamel® Flowable Microhybrid Medium Incisal, Syringe 3g
DeltaMed GmbH
7011MI
In Commercial Distribution

7011MI

  • Dental composite resin

Renamel® De-Mark™ - EDEL7011DM0

Renamel® De-Mark™, Syringe 3g
DeltaMed GmbH
7011DM
In Commercial Distribution

7011DM

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011D30

Renamel® Flowable Microhybrid Body D3, Syringe 3g
DeltaMed GmbH
7011D3
In Commercial Distribution

7011D3

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011CO0

Renamel® Flowable Microhybrid Clear Occlusal, Syringe 3g
DeltaMed GmbH
7011CO
In Commercial Distribution

7011CO

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011C40

Renamel® Flowable Microhybrid Body C4, Syringe 3g
DeltaMed GmbH
7011C4
In Commercial Distribution

7011C4

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011C30

Renamel® Flowable Microhybrid Body C3, Syringe 3g
DeltaMed GmbH
7011C3
In Commercial Distribution

7011C3

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011C20

Renamel® Flowable Microhybrid Body C2, Syringe 3g
DeltaMed GmbH
7011C2
In Commercial Distribution

7011C2

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011B30

Renamel® Flowable Microhybrid Body B3, Syringe 3g
DeltaMed GmbH
7011B3
In Commercial Distribution

7011B3

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011B20

Renamel® Flowable Microhybrid Body B2, Syringe 3g
DeltaMed GmbH
7011B2
In Commercial Distribution

7011B2

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011B10

Renamel® Flowable Microhybrid Body B1, Syringe 3g
DeltaMed GmbH
7011B1
In Commercial Distribution

7011B1

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011A40

Renamel® Flowable Microhybrid Body A4, Syringe 3g
DeltaMed GmbH
7011A4
In Commercial Distribution

7011A4

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011A30

Renamel® Flowable Microhybrid Body A3, Syringe 3g
DeltaMed GmbH
7011A3
In Commercial Distribution

7011A3

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011A20

Renamel® Flowable Microhybrid Body A2, Syringe 3g
DeltaMed GmbH
7011A2
In Commercial Distribution

7011A2

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011A10

Renamel® Flowable Microhybrid Body A1, Syringe 3g
DeltaMed GmbH
7011A1
In Commercial Distribution

7011A1

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL70110W0

Renamel® Flowable Microhybrid Body White, Syringe 3g
DeltaMed GmbH
70110W
In Commercial Distribution

70110W

  • Dental composite resin

Renamel® Bulkfill - EDEL6722D21

Renamel® Bulkfill D2, 20 Compules
DeltaMed GmbH
6722D2
In Commercial Distribution

  • EDEL6722D20 ()
  • EDEL6722D21 ()
  • D7796722D21 ()
6722D2

  • Dental composite resin

Renamel® Bulkfill - EDEL6722C31

Renamel® Bulkfill C3, 20 Compules
DeltaMed GmbH
6722C3
In Commercial Distribution

  • EDEL6722C30 ()
  • EDEL6722C31 ()
  • D7796722C31 ()
6722C3

  • Dental composite resin

Renamel® Bulkfill - EDEL6722B11

Renamel® Bulkfill B1, 20 Compules
DeltaMed GmbH
6722B1
In Commercial Distribution

  • EDEL6722B10 ()
  • EDEL6722B11 ()
  • D7796722B11 ()
6722B1

  • Dental composite resin

Renamel® Bulkfill - EDEL6722B01

Renamel® Bulkfill B-Zero, 20 Compules
DeltaMed GmbH
6722B0
In Commercial Distribution

  • EDEL6722B00 ()
  • EDEL6722B01 ()
  • D7796722B01 ()
6722B0

  • Dental composite resin
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