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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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SDR® Plus Bulk Fill Flowable - D00261C101P1

SDR® Plus Compula Refill - Shade Universal
DENTSPLY INTERNATIONAL INC.
61C101P
In Commercial Distribution

  • D00261C101P0 ()
  • D00261C101P1 ()
61C101P

  • Dental composite resin

Calm-it™ Desensitizer - D00261A1001

Calm-it™ Unit Dose Sample
DENTSPLY INTERNATIONAL INC.
61A100
Not in Commercial Distribution

  • D00261A1001 ()

  • 1 Calm-it™ Desensitizer Unit Dose
61A100

  • Dental cavity varnish

Regisil® Rigid Super Fast Set Cartridge System - D0026194251

Regisil® Rigid Super Fast Set VPS Bite Reg Material (Purple), Cartridge System Refill Package
DENTSPLY INTERNATIONAL INC.
619425
In Commercial Distribution

  • D00261942582 ()
  • D0026194251 ()
  • D0026194250 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619425

  • Silicone dental impression material

FluoroCore® 2+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement - D0026126001

FluoroCore® 2+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
612600
In Commercial Distribution

  • D0026126001 ()
612600

  • Dental composite resin

FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement - D0026124061

FluoroCore® 2+ Evaluator Kit
DENTSPLY INTERNATIONAL INC.
612406
In Commercial Distribution

  • D0026124061 ()

  • 1 Syringe (tooth colored), 10 Intraoral Tips, 10 Mixing Tips, 10 Endo Intraoral Tips
612406

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026075001

Calibra® Veneer Kit
DENTSPLY INTERNATIONAL INC.
607500
In Commercial Distribution

  • D0026075001 ()
607500

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607410NA1

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

  • D002607410NA1 ()

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

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026073001

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 Esthetic Resin Cement - D0026072061

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

  • D0026072061 ()
607206

  • Dental composite resin

Calibra® Veneer Esthetic Resin Cement - D0026072040

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® Ceram Adhesive Resin Cement - D0026071960

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 - D0026071950

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 - D0026071940

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 - D0026071920

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 - D0026071910

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 with Celtra® Duo (ZLS) Blocks - D0026071031

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 - D0026071010

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® 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 - 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

Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System - D0026786961

Aquasil Ultra+ digit Power LV RS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678696
In Commercial Distribution

  • D0026786960 ()
  • D0026786961 ()
678696

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786951

Aquasil® Ultra+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
678695
In Commercial Distribution

  • D0026786951 ()

  • 2 AU+ Heavy FS 50mL cartridges, 1 AU+ LV FS 50mL cartridge, 1 AU+ XLV FS 50mL cartridge, 12 mix tips, 6 intraoral tips, 1 bottle (14mL) Caulk tray adhesive, 1 AU+ digit LV/XLV FS evaulator kit
  • Total Volume: 50 Milliliter
678695

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System - D0026786941

Aquasil Ultra+ digit Power LV FS Small Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678694
In Commercial Distribution

  • D0026786940 ()
  • D0026786941 ()
678694

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System - D0026786931

Aquasil Ultra+ digit Power XLV RS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678693
In Commercial Distribution

  • D0026786930 ()
  • D0026786931 ()
678693

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786881

Aquasil® Ultra+ Rigid Fast Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678688
In Commercial Distribution

  • D00267868832 ()
  • D0026786881 ()
  • D0026786880 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678688

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786861

Aquasil® Ultra+ Heavy Regular Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678686
In Commercial Distribution

  • D00267868632 ()
  • D0026786861 ()
  • D0026786860 ()

  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
  • Total Volume: 380 Milliliter
678686

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786841

Aquasil® Ultra+ Heavy Fast Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678684
In Commercial Distribution

  • D00267868432 ()
  • D0026786841 ()
  • D0026786840 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678684

  • Silicone dental impression material

Aquasil® Ultra Monophase Smart Wetting® Impression Material - D0026786821

Aquasil® Ultra+ Medium Regular Set DECA 5:1 (2-pack)
DENTSPLY INTERNATIONAL INC.
678682
In Commercial Distribution

  • D00267868232 ()
  • D0026786821 ()
  • D0026786820 ()

  • Total Volume: 380 Milliliter
  • 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring
678682

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786781

Aquasil® Ultra+ Rigid Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678678
In Commercial Distribution

  • D00267867882 ()
  • D0026786781 ()
  • D0026786780 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678678

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786761

Aquasil® Ultra+ Heavy Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678676
In Commercial Distribution

  • D00267867682 ()
  • D0026786761 ()
  • D0026786760 ()

  • 32 (50mL) cartridges, 12 mixing tips
  • Total Volume: 50 Milliliter
678676

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786741

Aquasil® Ultra+ Medium Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678674
In Commercial Distribution

  • D00267867482 ()
  • D0026786741 ()
  • D0026786740 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678674

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786731

Aquasil® Ultra+ Medium Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678673
In Commercial Distribution

  • D00267867382 ()
  • D0026786731 ()
  • D0026786730 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips
678673

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786721

Aquasil® Ultra+ LV Fast Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678672
In Commercial Distribution

  • D00267867282 ()
  • D0026786721 ()
  • D0026786720 ()

  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
  • Total Volume: 50 Milliliter
678672

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786711

Aquasil® Ultra+ LV Regular Set 50mL 4-pack
DENTSPLY INTERNATIONAL INC.
678671
In Commercial Distribution

  • D00267867182 ()
  • D0026786711 ()
  • D0026786710 ()

  • Total Volume: 50 Milliliter
  • 32 (50mL) cartridges, 12 mixing tips, 12 intraoral tips
678671

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786491

Aquasil® Ultra+ Starter Kit
DENTSPLY INTERNATIONAL INC.
678649
In Commercial Distribution

  • D0026786491 ()
678649

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786481

Aquasil Ultra+ DECA Heavy/XLV Extended Set Kit
DENTSPLY INTERNATIONAL INC.
678648
Not in Commercial Distribution

  • D0026786481 ()
678648

  • Silicone dental impression material

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026786451

Aquasil® Ultra+ XLV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678645
In Commercial Distribution

  • D0026786451 ()
  • D0026786450 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678645

  • Silicone dental impression material

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026786441

Aquasil® Ultra+ XLV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678644
In Commercial Distribution

  • D0026786441 ()
  • D0026786440 ()

  • Total Volume: 2.4 Milliliter
  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
678644

  • Silicone dental impression material

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026786431

Aquasil® Ultra+ XLV Regular Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678643
In Commercial Distribution

  • D0026786431 ()
  • D0026786430 ()

  • Total Volume: 1.6 Milliliter
  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
678643

  • Silicone dental impression material

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663500

Integrity® Temporary Crown and Bridge Material, A1, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666350
In Commercial Distribution

  • D0026663500 ()

  • Weight: 15 Gram
  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
666350

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663450

Integrity® Temporary Crown and Bridge Material, Bleach White, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666345
In Commercial Distribution

  • D0026663450 ()

  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
  • Weight: 15 Gram
666345

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663400

Integrity® Temporary Crown and Bridge Material, B1, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666340
In Commercial Distribution

  • D0026663400 ()

  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
  • Weight: 15 Gram
666340

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663300

Integrity® Temporary Crown and Bridge Material, A3.5, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666330
In Commercial Distribution

  • D0026663300 ()

  • Weight: 15 Gram
  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
666330

  • Temporary dental crown/bridge

Integrity® Temporary Crown & Bridge Material mini-SYRINGE - D0026663200

Integrity® Temporary Crown and Bridge Material, A2, mini-SYRINGE Refill
DENTSPLY INTERNATIONAL INC.
666320
In Commercial Distribution

  • D0026663200 ()

  • 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips
  • Weight: 15 Gram
666320

  • Temporary dental crown/bridge

AutoMatrix® Retainerless Matrix System - D0026630321

AutoMatrix Retainerless Matrix System Introductory Kit
DENTSPLY INTERNATIONAL INC.
663032
In Commercial Distribution

  • D0026630321 ()

  • 96x bands (24 each size) , 1x tightening device, 1x Snippers, 6x catch trays
663032

  • Dental matrix band, single-use

AH PLUS JET - D0106670071

AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
667007
In Commercial Distribution

  • D0106670071 ()
  • D0106670070 ()

  • Paste
  • Weight: 15 Gram
667007

  • Endodontic filling/sealing material

AH PLUS JET - D0106670051

AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667005
In Commercial Distribution

  • D0106670051 ()

  • Weight: 15 Gram
  • Paste
667005

  • Endodontic filling/sealing material

AH PLUS ROOTCANAL - D0106670031

AH Plus Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B. With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667003
In Commercial Distribution

  • D0106670031 ()

  • Paste
  • Total Volume: 4 Milliliter
667003

  • Endodontic filling/sealing material

SmartLite Focus - D010644500501

SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450050
In Commercial Distribution

  • D010644500501 ()

  • Length: 7.5 Centimeter
64450050

  • Dental/surgical polymerization lamp
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