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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 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

Aquasil® Ultra+ digit® Smart Wetting® Impression Material - D0026786421

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+ digit® Smart Wetting® Impression Material - D0026786411

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+ digit® Smart Wetting® Impression Material - D0026786401

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+ Smart Wetting® Impression Material - D0026786271

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+ Smart Wetting® Impression Material - D0026786261

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+ Smart Wetting® Impression Material - D0026786251

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+ Smart Wetting® Impression Material - D0026786021

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+ Smart Wetting® Impression Material - D0026786011

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 Smart Wetting® Impression Material - D0026784501

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 Smart Wetting® Impression Material - D0026782761

Aquasil Ultra Heavy FS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678276
In Commercial Distribution

  • D0026782760 ()
  • D0026782761 ()
678276

  • Silicone dental impression material

International Dental Supply Fluoroseal Cavity Liner - D801ID75035IZ1

Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Ziploc Bag. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 75-035 IZ
In Commercial Distribution

  • D801ID75035IZ1 ()
75-035

  • Dental cavity varnish

SciPharm CuRay Match Metal Primer - D801ID7010I1

SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

  • Dental composite resin

International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive - D801ID6005I1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-05 I
In Commercial Distribution

  • D801ID6005I1 ()
60-05

  • Dentine adhesive

International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive - D801ID60052I1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive

International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive - D801ID60051I1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-051 I
In Commercial Distribution

  • D801ID60051I1 ()
60-05

  • Dentine adhesive

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50224I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Universal Opaque Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-224 I
In Commercial Distribution

  • D801ID50224I1 ()
50-224

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50222I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Incisal Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-222 I
In Commercial Distribution

  • D801ID50222I1 ()
50-222

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50219I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-219 I
In Commercial Distribution

  • D801ID50219I1 ()
50-219

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50218I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-218 I
In Commercial Distribution

  • D801ID50218I1 ()
50-218

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50217I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-217 I
In Commercial Distribution

  • D801ID50217I1 ()
50-217

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50216I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-216 I
In Commercial Distribution

  • D801ID50216I1 ()
50-216

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50215I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C3/D3Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-215 I
In Commercial Distribution

  • D801ID50215I1 ()
50-215

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50214I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-214 I
In Commercial Distribution

  • D801ID50214I1 ()
50-214

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50213I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A1/B1 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-213 I
In Commercial Distribution

  • D801ID50213I1 ()
50-213

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50212I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3.5 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-212 I
In Commercial Distribution

  • D801ID50212I1 ()
50-212

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50211I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-211
In Commercial Distribution

  • D801ID50211I1 ()
50-211

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50210I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-210
In Commercial Distribution

  • D801ID50210I1 ()
50-210

  • Dental composite resin

SciPharm CuRay Fil Light Cure Composite Resin - D801ID50121I1

Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin

Acu-Flow™ Bite Registration Cartridge - 00359883006631

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016399
In Commercial Distribution

  • 00359883006631 ()

  • Total Volume: 50 Milliliter
1-016399

  • Silicone dental impression material

Tissue Goo™ Hemostatic Gel 4-Pack - 00359883005665

Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
641904
In Commercial Distribution

  • 00359883005665 ()

  • Total Volume: 12 Milliliter
641904

  • Gingival retraction solution

Acu-Flow™ Rigid Tray Cartridge - 00359883003388

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016409
In Commercial Distribution

  • 00359883003388 ()

  • Total Volume: 50 Milliliter
1-016409

  • Silicone dental impression material

Acu-Flow™ Medium Body Cartridge - 00359883003371

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016408
In Commercial Distribution

  • 00359883003371 ()

  • Total Volume: 50 Milliliter
1-016408

  • Silicone dental impression material

Acu-Flow™ Heavy Body Cartridge - 00359883003364

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016407
In Commercial Distribution

  • 00359883003364 ()

  • Total Volume: 50 Milliliter
1-016407

  • Silicone dental impression material

Acu-Flow™ Light Body Plus Cartridge - 00359883003357

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016406
In Commercial Distribution

  • 00359883003357 ()

  • Total Volume: 50 Milliliter
1-016406

  • Silicone dental impression material

Acu-Flow™ Putty Kit - 00359883003340

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016405
In Commercial Distribution

  • 00359883003340 ()

  • Total Volume: 600 Milliliter
1-016405

  • Silicone dental impression material

Acu-Flow™ Monophase 6-Pack - 00359883003333

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016404
In Commercial Distribution

  • 00359883003326 ()
  • 00359883003333 ()

  • Total Volume: 300 Milliliter
1-016404

  • Silicone dental impression material

Acu-Flow™ Rigid Tray 6-Pack - 00359883003319

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016403
In Commercial Distribution

  • 00359883003302 ()
  • 00359883003319 ()

  • Total Volume: 300 Milliliter
1-016403

  • Silicone dental impression material

Acu-Flow™ Heavy Body 6-Pack - 00359883003296

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016402
In Commercial Distribution

  • 00359883003289 ()
  • 00359883003296 ()

  • Total Volume: 300 Milliliter
1-016402

  • Silicone dental impression material
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