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® Universal+ Sample
DENTSPLY INTERNATIONAL INC.
607410NA
In Commercial Distribution

  • D002607410NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607410NA

  • Dental composite resin
Calibra® Universal Sample Package
DENTSPLY INTERNATIONAL INC.
607410
In Commercial Distribution

  • D0026074101 ()

  • 1 Syringe (2g) and 10 Mixing Tips
607410

  • Dental composite resin
Calibra® Universal+ Syringe Refill - Bleach Shade
DENTSPLY INTERNATIONAL INC.
607407NA
In Commercial Distribution

  • D002607407NA0 ()
  • D002607407NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607407NA

  • Dental composite resin
Calibra® Universal Dual Cure Automix Syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607407
In Commercial Distribution

  • D0026074071 ()
  • D0026074070 ()

  • 2 Syringes (4.5g) each and 20 Mixing Tips
  • Weight: 4.5 Gram
607407

  • Dental composite resin
Calibra® Universal+ Syringe Refill - Opaque Shade
DENTSPLY INTERNATIONAL INC.
607406NA
In Commercial Distribution

  • D002607406NA0 ()
  • D002607406NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607406NA

  • Dental composite resin
Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Opaque, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607406
In Commercial Distribution

  • D0026074061 ()
  • D0026074060 ()

  • Weight: 4.5 Gram
  • 2 Dual Cure AutoMix Syringes (4.5g) - Opaque - and 20 Mixing Tips
607406

  • Dental composite resin
Calibra® Universal+ Syringe Refill - Translucent Shade
DENTSPLY INTERNATIONAL INC.
607405NA
In Commercial Distribution

  • D002607405NA0 ()
  • D002607405NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607405NA

  • Dental composite resin
Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Translucent, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607405
In Commercial Distribution

  • D0026074051 ()
  • D0026074050 ()

  • 2 Dual Cure AutoMix Syringes (4.5g) - Translucent - and 20 Mixing Tips
  • Weight: 4.5 Gram
607405

  • Dental composite resin
Calibra® Universal+ Syringe Refill - Medium Shade
DENTSPLY INTERNATIONAL INC.
607403NA
In Commercial Distribution

  • D002607403NA0 ()
  • D002607403NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607403NA

  • Dental composite resin
Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Medium, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607403
In Commercial Distribution

  • D0026074031 ()
  • D0026074030 ()

  • Weight: 4.5 Gram
  • 2 Dual Cure AutoMix Syringes (4.5g) - Medium - and 20 Mixing Tips
607403

  • Dental composite resin
Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Light, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607402
In Commercial Distribution

  • D0026074021 ()
  • D0026074020 ()

  • Weight: 4.5 Gram
  • 2 Dual Cure AutoMix Syringes (4.5g) - Light - and 20 Mixing Tips
607402

  • Dental composite resin
Calibra® Universal+ Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
607400NA
In Commercial Distribution

  • D002607400NA0 ()
  • D002607400NA1 ()

  • 5 Syringes (4.5g each), 1 in each shade (Light, Medium, Translucent, Opaque, Bleach); 50 Mixing Tips
607400NA

  • Dental composite resin
Calibra® Universal Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
607400
In Commercial Distribution

  • D0026074001 ()

  • 5 Dual Cure AutoMix Syringes (4.5g) - 1 each shade: Light, Medium, Translucent, Opaque, Bleach; 50 Mixing Tips
  • Weight: 4.5 Gram
607400

  • Dental composite resin
Calibra® Veneer Try-In Paste Syringe Refill Package - Bleach Shade
DENTSPLY INTERNATIONAL INC.
607306
In Commercial Distribution

  • D0026073060 ()
  • D0026073061 ()
607306

  • Dental composite resin
Calibra® Veneer Cement, Try-In Paste Refill Package, Opaque, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607305
In Commercial Distribution

  • D0026073051 ()
  • D0026073050 ()

  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Opaque
  • Weight: 1.8 Gram
607305

  • Dental composite resin
Calibra® Veneer Cement, Try-In Paste Refill Package, Translucent, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607304
In Commercial Distribution

  • D0026073041 ()
  • D0026073040 ()

  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Translucent
  • Weight: 1.8 Gram
607304

  • Dental composite resin
Calibra® Veneer Cement, Try-In Paste Refill Package, Medium, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607302
In Commercial Distribution

  • D0026073021 ()
  • D0026073020 ()

  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Medium
  • Weight: 1.8 Gram
607302

  • Dental composite resin
Calibra® Veneer Cement, Try-In Paste Refill Package, Light, 2 syringe (1.8g)
DENTSPLY INTERNATIONAL INC.
607301
In Commercial Distribution

  • D0026073011 ()
  • D0026073010 ()

  • Weight: 1.8 Gram
  • 2 Syringes Calibra® Veneer Try-In Paste (1.8g), Light
607301

  • Dental composite resin
Calibra® Veneer Cement Try-In Paste Accessory Pack
DENTSPLY INTERNATIONAL INC.
607300
In Commercial Distribution

  • D0026073001 ()

  • 5 Syringes Calibra® Veneer Try-In Paste (1.8g each) - 1 in each shade: Light, Medium, Dark, Opaque, Bleach
  • Weight: 1.8 Gram
607300

  • Dental composite resin
Calibra® Veneer Syringe Refill Package - Bleach Shade
DENTSPLY INTERNATIONAL INC.
607206
In Commercial Distribution

  • D0026072061 ()
607206

  • Dental composite resin
Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Opaque, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607205
In Commercial Distribution

  • D0026072050 ()

  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Opaque
  • Weight: 2 Gram
607205

  • Dental composite resin
Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Translucent, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607204
In Commercial Distribution

  • D0026072040 ()

  • Weight: 2 Gram
  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Translucent
607204

  • Dental composite resin
Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Medium, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607202
In Commercial Distribution

  • D0026072020 ()

  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Medium
  • Weight: 2 Gram
607202

  • Dental composite resin
Calibra® Veneer Cement Light Cure Syringe Refill Package, Base, Light, 1 syringe (2g)
DENTSPLY INTERNATIONAL INC.
607201
In Commercial Distribution

  • D0026072010 ()

  • 1 Syringe Light Cure Calibra® Veneer Cement (2g), Light
  • Weight: 2 Gram
607201

  • Dental composite resin
Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Bleach
DENTSPLY INTERNATIONAL INC.
607196
In Commercial Distribution

  • D0026071960 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607196

  • Dental composite resin
Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Opaque
DENTSPLY INTERNATIONAL INC.
607195
In Commercial Distribution

  • D0026071950 ()

  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
  • Weight: 4.5 Gram
607195

  • Dental composite resin
Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Translucent
DENTSPLY INTERNATIONAL INC.
607194
In Commercial Distribution

  • D0026071940 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607194

  • Dental composite resin
Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Medium
DENTSPLY INTERNATIONAL INC.
607192
In Commercial Distribution

  • D0026071920 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607192

  • Dental composite resin
Calibra® Ceram Adhesive Resin Cement Syringe Refill - Shade Light
DENTSPLY INTERNATIONAL INC.
607191
In Commercial Distribution

  • D0026071910 ()

  • Weight: 4.5 Gram
  • 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips
607191

  • Dental composite resin
CEREC® Essentials Combo Kit with Celtra® Duo (ZLS) Blocks
DENTSPLY INTERNATIONAL INC.
607103
Not in Commercial Distribution

  • D0026071031 ()

  • 4 blocks, 3 Firing Pads, 1 Syringe Coupling Agent, 1 Overglaze, 1 Stain & Glaze Liquid, 1 Calibra Ceram Syringe, 10 mix tips, 1 mixing well, 1 bottle Prime&Bond elect, 25 flocked applicator tips
607103

  • Dental appliance fabrication material, ceramic
Calibra® Ceram Adhesive Resin Cement Syringe Sample Package
DENTSPLY INTERNATIONAL INC.
607101
In Commercial Distribution

  • D0026071010 ()

  • 1 Dual Cure AutoMix Syringe (2g) Shade Translucent and 10 Mixing Tips
  • Weight: 2 Gram
607101

  • Dental composite resin
Calibra® Cement Automix Syringe Mixing Tip Refill
DENTSPLY INTERNATIONAL INC.
607086
In Commercial Distribution

  • D0026070861 ()
  • D0026070860 ()

  • 50 Mixing Tips
607086

  • Dental composite resin
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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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 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, 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
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+ 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+ XLV Extended Set (Orange)
DENTSPLY INTERNATIONAL INC.
678702
Not in Commercial Distribution

  • D0026787020 ()
  • D0026787021 ()
678702

  • Silicone dental impression material
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