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

  • D0026786481 ()
678648

  • Silicone dental impression material
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+ 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+ 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 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 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 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 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 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 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 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 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 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 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 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 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+ 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
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® 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® 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
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