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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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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

SmartLite Focus - D010644500401

SmartLite Focus Eye Protection Sields are a part of the SmartLite Focus Curing Light and are available separately.
Dentsply De Trey GmbH
64450040
In Commercial Distribution

  • D010644500400 ()
  • D010644500401 ()

  • Outer Diameter: 2 Centimeter
64450040

  • Dental/surgical polymerization lamp

SmartLite Focus - D010644500211

SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450021
In Commercial Distribution

  • D010644500211 ()

  • Length: 5.9 Centimeter
64450021

  • Dental/surgical polymerization lamp

Automatrix Snippers+ - D010624226011

Automatrix Snippers+ is a scissors-like tool for removal of Automatrix system bands by clipping off the Auto-Lock loop.
Dentsply De Trey GmbH
62422601
In Commercial Distribution

  • D010ASN0 ()
  • D010624226011 ()

  • Length: 17 Centimeter
62422601

  • Orthodontic pliers

VISCOGEL - D010616050021

VISCO GEL Standard Pack is a self-curing, resilient methacrylate formulation, intended for use as a limited-term soft linig material for complet and partial dentures. Visco-gel is received in 2 components powder (D010K2006000) and liquid (D010K3006010) both of them in a bottle delivery. With an additional bottle of a separator (D010K3006020) and its supporting accessories (Mixing Bowl, Powder Measure and Liquid Measure) it can be classified as a convenience kit.
Dentsply De Trey GmbH
61605002
In Commercial Distribution

  • D010616050021 ()

  • Weight: 120 Gram
  • Liquid
  • Total Volume: 15 Milliliter
  • Total Volume: 90 Milliliter
  • Powder
61605002

  • Denture reliner, soft, professional

Prime&Bond active - D010606673541

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667354
In Commercial Distribution

  • D010606673541 ()
60667354

  • Dentine bonding agent/set

Prime&Bond active - D010606673531

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667353
In Commercial Distribution

  • D010606673531 ()
60667353

  • Dentine bonding agent/set

Prime&Bond active - D010606673481

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667348
In Commercial Distribution

  • D010606673481 ()
60667348

  • Dentine bonding agent/set

Prime&Bond active - D010606673471

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667347
In Commercial Distribution

  • D010606673471 ()
60667347

  • Dentine bonding agent/set

Prime&Bond active - D010606673451

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667345
In Commercial Distribution

  • D010606673451 ()
60667345

  • Dentine bonding agent/set

Prime&Bond active - D010606673441

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667344
In Commercial Distribution

  • D010606673441 ()
60667344

  • Dentine bonding agent/set

Prime&Bond active - D010606673431

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667343
In Commercial Distribution

  • D010606673431 ()
60667343

  • Dentine bonding agent/set

Prime&Bond active - D010606673421

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667342
In Commercial Distribution

  • D010606673421 ()
60667342

  • Dentine bonding agent/set

Prime&Bond active - D010606673411

Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self Etch and Selective Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667341
In Commercial Distribution

  • D010606673411 ()

  • liquid
  • Total Volume: 4 Milliliter
60667341

  • Dentine bonding agent/set

Prime&Bond active - D010606673401

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667340
In Commercial Distribution

  • D010606673401 ()
60667340

  • Dentine bonding agent/set

AH Plus Jet Endodontic Sealer Syringe Refill - D01060620118NA1

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
60620118NA
In Commercial Distribution

  • D01060620118NA0 ()
  • D01060620118NA1 ()

  • Weight: 30 Gram
60620118NA

  • Dental epoxy resin

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

Dentsply Sirona - D0026344020

Amalgam Bonding Accessory Kit
DENTSPLY INTERNATIONAL INC.
634402
In Commercial Distribution

  • D0026344020 ()
634402

  • Dentine bonding agent/set

Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive - D0026343561

Prime&Bond® NT™ Light Cured Dental Adhesive Unit Dose Package
DENTSPLY INTERNATIONAL INC.
634356
In Commercial Distribution

  • D0026343561 ()
  • D0026343560 ()

  • 80 Unit Doses Prime&Bond® NT™, 4 Unit Dose Holders, 100 Flocked Applicator tips
634356

  • Dentine adhesive

Self Cure Activator - D002634354K1

Self Cure Activator Refill Package
DENTSPLY INTERNATIONAL INC.
634354K
In Commercial Distribution

  • D002634354K1 ()

  • 1 Bottle (4.5 mL)
634354K

  • Dentine bonding agent/set

Self Cure Activator - D0026343540

Self Cure Activator Refill
DENTSPLY INTERNATIONAL INC.
634354
In Commercial Distribution

  • D0026343540 ()

  • Total Volume: 4.5 Milliliter
  • One 4.5mL bottle Self Cure Activator
634354

  • Dentine adhesive

Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive - D0026343531

Prime&Bond® NT™ Nano-Technology Dental Adhesive Dual Cure Introductory Kit
DENTSPLY INTERNATIONAL INC.
634353
In Commercial Distribution

  • D0026343531 ()

  • Total Volume: 4.5 Milliliter
  • 1 Bottle Adhesive, 1 Bottle Activator, 1 Syringe Tooth Conditioner Gel, 25 Applicator Tips, 1 Brush Handle, 80 Disposable Brush Tips, 1 Dispensing Well
634353

  • Dentine adhesive

Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive - D0026343521

Total Etch Adhesive, 2 (4.5ml) Bottle Refill Package
DENTSPLY INTERNATIONAL INC.
634352
In Commercial Distribution

  • D00263435262 ()
  • D0026343521 ()
  • D0026343520 ()

  • Total Volume: 4.5 Milliliter
  • 2 Bottles Total Etch Adhesive (4.5mL)
634352

  • Dentine adhesive

Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive - D0026343511

Prime&Bond® NT™ Total Etch Adhesive Bottle Economy Package
DENTSPLY INTERNATIONAL INC.
634351
In Commercial Distribution

  • D00263435162 ()
  • D0026343511 ()

  • Total Volume: 3 Milliliter
  • 3 Bottles Adhesive, 120 Disposable Brush Tips, 1 Brush Handle, 2 Syringes Tooth Conditioner Gel, 75 Applicator Tips (Needles), 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
634351

  • Dentine adhesive

Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive - D0026343501

Prime&Bond® NT™ Nano-Technology Dental Adhesive Introductory Kit
DENTSPLY INTERNATIONAL INC.
634350
In Commercial Distribution

  • D0026343501 ()

  • 1 Bottle P&B Adhesive (4.5mL), 40 Disposable Brush Tips, 1 Brush Handle, 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
634350

  • Dentine adhesive

Prisma® Gloss™ Composite Polishing Paste System - D0026314500

Prisma® Gloss™ Composite Polishing Paste System Syringe Refill - Extra Fine
DENTSPLY INTERNATIONAL INC.
631450
In Commercial Distribution

  • D00263145042 ()
  • D0026314500 ()

  • 1 Syringe Polishing Paste Extra Fine (4g)
  • Weight: 4 Gram
631450

  • Dental unfilled resin sealant/coating

Prisma® Gloss™ Composite Polishing Paste System - D0026314000

Prisma® Gloss™ Composite Polishing Paste System Syringe Refill
DENTSPLY INTERNATIONAL INC.
631400
In Commercial Distribution

  • D00263140042 ()
  • D0026314000 ()

  • 1 Syringe Polishing Paste (4g)
  • Weight: 4 Gram
631400

  • Dental unfilled resin sealant/coating

Quixx® Posterior Restorative - D0026312031

Quixx® Posterior Restorative Evaluator Package
DENTSPLY INTERNATIONAL INC.
631203
In Commercial Distribution

  • D0026312030 ()
  • D0026312031 ()

  • 5 Compules(r) Tips (0.28g each) Universal Shade
631203

  • Dental composite resin

Esthet-X® HD - D0026306061

Esthet-X® HD Compule Sampler - Shade A2
DENTSPLY INTERNATIONAL INC.
630606
Not in Commercial Distribution

  • D0026306060 ()
  • D0026306061 ()

  • 3 Compules® Tips - Shade A2
630606

  • Dental composite resin
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