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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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GRADIA® - D0470036511

GRADIA® CORE Kit (1CORE Cartridge 10 mL (20 g), 1 SE Bonding Liquid A 3 mL, 1 SE Bond Liquid B 1.5 mL, 25 Micro-Tip applicators, 1 Applicator holder, 1 Dispensing dish, 20 GC Automix Tips for Endo, 20 Extension Tips)
Gc America Inc.
003651
Not in Commercial Distribution

  • D0470036511 ()
003651

  • Dental composite resin

ZenithDental - D033611811

ZenithDental Anterior/Posterior Hybrid Visible Light Cured Universal (u)
DMG AMERICA, LLC
61181
In Commercial Distribution

  • D033611811 ()

  • Weight: 3 Gram
003-61181

  • Dental composite resin

Quala - D023Q402541

Quala Flowable Composite A3.5 2.5G 20 TIPS/PK
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q40254
In Commercial Distribution

  • D023Q402541 ()
Q40254

  • Dental composite resin

Quala - D023Q402521

Quala Flowable Composite A2 2X2G 20 TIPS/PK
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q40252
In Commercial Distribution

  • D023Q402521 ()
Q40252

  • Dental composite resin

Quala - D023Q402551

Quala Flowable Composite B1 2X2G 20TIPS/PK
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q40255
In Commercial Distribution

  • D023Q402551 ()
Q40255

  • Dental composite resin

Quala - D023Q402531

Quala Flowable Composite A3 2X2G 20TIPS/PK
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q40253
In Commercial Distribution

  • D023Q402531 ()
Q40253

  • Dental composite resin

Quala - D023Q402511

Quala Flowable Composite A1 2x2G
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q40251
In Commercial Distribution

  • D023Q402511 ()
Q40251

  • Dental composite resin

Quala - D023Q4020117

Quala Core Buildup Dual Cure 2x9G 20 Mix Tip
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q40201
In Commercial Distribution

  • D023Q4020117 ()
Q40201

  • Dental composite resin

TPH Spectra ST flow - D0106425321

TPH Spectra ST flow Syringe Discovery Kit is a visible light cured, radiopaque composite resin restorative material with flow characteristics that make it ideal for use in anterior and posterior teeth.
Dentsply De Trey GmbH
642532
In Commercial Distribution

  • D0106425321 ()
642532

  • Dental composite resin

TPH Spectra ST - D0106424751

TPH Spectra ST Syringe Refill HV BW is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.
Dentsply De Trey GmbH
642475
In Commercial Distribution

  • D0106424751 ()

  • Paste
  • Weight: 3 Gram
642475

  • Dental composite resin
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