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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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AH PLUS JET - D010606201181

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 (D010606201180) delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
60620118
In Commercial Distribution

  • D010606201181 ()
  • D010606201180 ()

  • Weight: 15 Gram
  • Paste
60620118

  • Endodontic filling/sealing material

AH Plus Jet Endodontic Sealer Starter Kit - D01060620115NA1

AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
Dentsply De Trey GmbH
60620115NA
In Commercial Distribution

  • D01060620115NA1 ()

  • Weight: 15 Gram
60620115NA

  • Dental epoxy resin

AH PLUS JET - D010606201151

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 (D010K3001600) 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
60620115
In Commercial Distribution

  • D010606201151 ()

  • Weight: 15 Gram
  • Paste
60620115

  • Endodontic filling/sealing material

Mixint Tip / Intraoral Tip - D01060620111

Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material

AH Plus Endodontic Sealer Tubes - D01060620110NA1

AH Plus endodontic sealer in tubes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin for an easy manual mix. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
Dentsply De Trey GmbH
60620110NA
In Commercial Distribution

  • D01060620110NA1 ()

  • Total Volume: 8 Milliliter
60620110NA

  • Dental epoxy resin

AH PLUS ROOTCANAL - D010606201101

AH Plus Refill 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 (D010K3018020 and D010K3018030). With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60620110
In Commercial Distribution

  • D010606201101 ()

  • Paste
  • Total Volume: 4 Milliliter
60620110

  • Endodontic filling/sealing material

AH 26 - D010606201011

AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120)
Dentsply De Trey GmbH
60620101
In Commercial Distribution

  • D010606201011 ()
  • D010606201010 ()

  • Weight: 8 Gram
  • Paste
  • Powder
  • Weight: 10 Gram
60620101

  • Endodontic filling/sealing material

AH 26 - D010606200021

AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin root canal filling material containing a resin tube (D010K3019120).
Dentsply De Trey GmbH
60620002
In Commercial Distribution

  • D010606200021 ()

  • Paste
  • Weight: 10 Gram
60620002

  • Endodontic filling/sealing material

Capsule Extruder 2 - D010606065961

Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules
Dentsply De Trey GmbH
60606596
In Commercial Distribution

  • D010606065960 ()
  • D010606065961 ()

  • Length: 17.5 Centimeter
60606596

  • Dental material cartridge-plunging applicator, single-component

SDR® Plus Bulk Fill Flowable - D010606030481

SDR® Plus Collectors Edition
DENTSPLY INTERNATIONAL INC.
60603048
In Commercial Distribution

  • D010606030481 ()
60603048

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D010606030471

SDR® Plus Compula Intro Kit
DENTSPLY INTERNATIONAL INC.
60603047
In Commercial Distribution

  • D010606030471 ()
60603047

  • Dental composite resin

SDR® Plus Bulk Fill Flowable - D010606030451

SDR® Plus Syringe ECO Refill
DENTSPLY INTERNATIONAL INC.
60603045
In Commercial Distribution

  • D010606030450 ()
  • D010606030451 ()
60603045

  • Dental composite resin

Seal & Protect™ - D0036580101

Seal & Protect™ Protective Sealant for Exposed Dentin. Contains: 2 Holders, 50 Brush Stixx
Dentsply Professional
658010
In Commercial Distribution

  • D0036580101 ()


  • Dental unfilled resin sealant/coating

DELTON® - D0033102011

DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Refill Kit. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310201
In Commercial Distribution

  • D0033102012 ()
  • D0033102011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin

DELTON® - D0033101011

DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.
Dentsply Professional
310101
In Commercial Distribution

  • D0033101012 ()
  • D0033101011 ()

  • Weight: 1.9 Gram


  • Cable/lead/sensor/probe cover, non-sterile
  • Dental composite resin

DELTON® - D00328961

DELTON® PLUS Pit & Fissure Sealant with Fluoride Direct Delivery System Light Curing, Opaque. Contents: 50 DDS Cartridges of 4 ml.
Dentsply Professional
2896
In Commercial Distribution

  • D00328962 ()
  • D00328961 ()
  • D00328960 ()


  • Dental composite resin

DELTON® - D00328941

DELTON® PLUS Pit & Fissure Sealant with FLUORIDE Direct Delivery System Light Curing, Opaque. Contents: 1 DDS Autoclavable Applicator, 50 Cartridges of 4 ml Sealant, EZ Etch Syringe of 3ml, 25 Etch Brush Tips.
Dentsply Professional
2894
In Commercial Distribution

  • D00328942 ()
  • D00328941 ()


  • Dental composite resin

DELTON® - D003279751

DELTON® Regular Kit Light Curing Pit & Fissure Sealant, Opaque. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.
Dentsply Professional
27975
In Commercial Distribution

  • D003279752 ()
  • D003279751 ()


  • Dental unfilled resin sealant/coating

DELTON® - D003279651

DELTON® Regular Kit Light Curing Pit and Fissure Sealant, Clear. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays.
Dentsply Professional
27965
In Commercial Distribution

  • D003279652 ()
  • D003279651 ()


  • Dental unfilled resin sealant/coating

DELTON® - D00326961

DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Opaque. Contains: 50 Cartridges - 4 ml
Dentsply Professional
2696
In Commercial Distribution

  • D00326962 ()
  • D00326961 ()
  • D00326960 ()

  • Total Volume: 4 Milliliter


  • Dental unfilled resin sealant/coating

DELTON® - D00326951

DELTON® Pit & Fissure Sealant Direct Delivery System Light Curing Clear. Contains: 50 Cartridges - 4 ml
Dentsply Professional
2695
In Commercial Distribution

  • D00326952 ()
  • D00326951 ()
  • D00326950 ()

  • Total Volume: 4 Milliliter


  • Dental unfilled resin sealant/coating

DELTON® - D00321031

EZ Etch 34% Etchant Gel. Contains: 2 Syringes (3 mL each) and 25 Tips.
Dentsply Professional
2103
In Commercial Distribution

  • D00321032 ()
  • D00321031 ()

  • Total Volume: 3 Milliliter


  • Dental etching solution

Comspan® Composite Luting Cement - D0029552511

Comspan Composite Luting Cement Opaque Catalyst
DENTSPLY INTERNATIONAL INC.
955251
In Commercial Distribution

  • D0029552511 ()

  • 1x jar Catalyst (5g)
  • Weight: 5 Gram
955251

  • Dental composite resin

Comspan® Composite Luting Cement - D0029552501

Comspan Composite Luting Cement Opaque Base
DENTSPLY INTERNATIONAL INC.
955250
In Commercial Distribution

  • D0029552501 ()

  • 1x jar Base (5g)
  • Weight: 5 Gram
955250

  • Dental composite resin

Prime&Bond® XP - D0026930021

Prime&Bond® XP Etch&Rinse Adhesive Unit Dose Package
DENTSPLY INTERNATIONAL INC.
693002
In Commercial Distribution

  • D0026930020 ()
  • D0026930021 ()
693002

  • Dentine bonding agent/set

Aquasil® Ultra Smart Wetting® Impression Material - D0026787811

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 Smart Wetting® Impression Material - D0026787791

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 Smart Wedding Impression Material - D002678769KR1

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+ Smart Wetting® Impression Material - D0026787141

Aquasil Ultra+ XLV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678714
In Commercial Distribution

  • D0026787140 ()
  • D0026787141 ()
678714

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787131

Aquasil Ultra+ LV FS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678713
In Commercial Distribution

  • D0026787130 ()
  • D0026787131 ()
678713

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787071

Aquasil Ultra+ XLV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678707
In Commercial Distribution

  • D0026787070 ()
  • D0026787071 ()
678707

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787061

Aquasil Ultra+ LV RS 2-Pack Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678706
In Commercial Distribution

  • D0026787060 ()
  • D0026787061 ()
678706

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787041

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+ Smart Wetting® Impression Material - D0026787031

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+ Smart Wetting® Impression Material - D0026787021

Aquasil Ultra+ XLV Extended Set (Orange)
DENTSPLY INTERNATIONAL INC.
678702
Not in Commercial Distribution

  • D0026787020 ()
  • D0026787021 ()
678702

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026787011

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+ Smart Wedding Impression Material - D0026786990

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 Smart Wetting® Impression Material in digit® Delivery System - D0026786981

Aquasil Ultra+ digit Power XLV FS Cartridge Refill
DENTSPLY INTERNATIONAL INC.
678698
In Commercial Distribution

  • D0026786980 ()
  • D0026786981 ()
678698

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786971

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 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
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