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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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TEMPSMART™ - D6584200001

TEMPSMART™ 48mL Mixing Tip II SSS (20)
Gc America Inc.
420000
In Commercial Distribution

  • D6584200001 ()
  • D6584200000 ()
420000

  • Dental material application tool, single-use

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

G-aenial™ - D0470091771

G-aenial™ Sculpt 20 Unitip C3 (0.16mL each)
Gc America Inc.
009177
In Commercial Distribution

  • D0470091771 ()
  • D0470091770 ()
009177

  • Light-cured dental restorative composite resin

G-aenial™ - D0470091761

G-aenial™ Sculpt 20 Untip B3 (0.16mL each)
Gc America Inc.
009176
In Commercial Distribution

  • D0470091761 ()
  • D0470091760 ()
009176

  • Light-cured dental restorative composite resin

G-aenial™ - D0470091751

G-aenial™ Sculpt 20 Unitip B2 (0.16mL each)
Gc America Inc.
009175
In Commercial Distribution

  • D0470091751 ()
  • D0470091750 ()
009175

  • Light-cured dental restorative composite resin

G-aenial™ - D0470091741

G-aenial™ Sculpt 20 Unitip B1 (0.16mL each)
Gc America Inc.
009174
In Commercial Distribution

  • D0470091741 ()
  • D0470091740 ()
009174

  • Light-cured dental restorative composite resin

G-aenial™ - D0470091731

G-aenial™ Sculpt 20 Unitip A4 (0.16mL each)
Gc America Inc.
009173
In Commercial Distribution

  • D0470091731 ()
  • D0470091730 ()
009173

  • Light-cured dental restorative composite resin

G-aenial™ - D0470091721

G-aenial™ Sculpt 20 Unitip A3.5 (0.16mL each)
Gc America Inc.
009172
In Commercial Distribution

  • D0470091721 ()
  • D0470091720 ()
009172

  • Light-cured dental restorative composite resin

G-aenial™ - D0470091711

G-aenial™ Sculpt 20 Unitip A3 (0.16mL each)
Gc America Inc.
009171
In Commercial Distribution

  • D0470091711 ()
  • D0470091710 ()
009171

  • Light-cured dental restorative composite resin
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