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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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Resin root canal sealer for dental endodontic treatment
MICRO MEGA
none
In Commercial Distribution

  • J015206000360 ()
20600106

  • Endodontic filling/sealing material
Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution

  • 00860001523218 ()
PFL-02PV

  • Custom-made organ/bone anatomy model
Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
Enamelize™, Tube 36g
DeltaMed GmbH
906101
In Commercial Distribution

906101

  • Dentifrice
Enamelize™, Syringe 3g
DeltaMed GmbH
906000
In Commercial Distribution

906000

  • Dentifrice
Renamel® Flowable Microhybrid Milky White Occlusal, Syringe 3g
DeltaMed GmbH
701MWO
In Commercial Distribution

701MWO

  • Dental composite resin
Renamel® Flowable Microhybrid Body A3.5, Syringe 3g
DeltaMed GmbH
701A35
In Commercial Distribution

701A35

  • Dental composite resin
Renamel® Flowable Microhybrid Medium Incisal, Syringe 3g
DeltaMed GmbH
7011MI
In Commercial Distribution

7011MI

  • Dental composite resin
Renamel® De-Mark™, Syringe 3g
DeltaMed GmbH
7011DM
In Commercial Distribution

7011DM

  • Dental composite resin
Renamel® Flowable Microhybrid Body D3, Syringe 3g
DeltaMed GmbH
7011D3
In Commercial Distribution

7011D3

  • Dental composite resin
Renamel® Flowable Microhybrid Clear Occlusal, Syringe 3g
DeltaMed GmbH
7011CO
In Commercial Distribution

7011CO

  • Dental composite resin
Renamel® Flowable Microhybrid Body C4, Syringe 3g
DeltaMed GmbH
7011C4
In Commercial Distribution

7011C4

  • Dental composite resin
Renamel® Flowable Microhybrid Body C3, Syringe 3g
DeltaMed GmbH
7011C3
In Commercial Distribution

7011C3

  • Dental composite resin
Renamel® Flowable Microhybrid Body C2, Syringe 3g
DeltaMed GmbH
7011C2
In Commercial Distribution

7011C2

  • Dental composite resin
Renamel® Flowable Microhybrid Body B3, Syringe 3g
DeltaMed GmbH
7011B3
In Commercial Distribution

7011B3

  • Dental composite resin
Renamel® Flowable Microhybrid Body B2, Syringe 3g
DeltaMed GmbH
7011B2
In Commercial Distribution

7011B2

  • Dental composite resin
Renamel® Flowable Microhybrid Body B1, Syringe 3g
DeltaMed GmbH
7011B1
In Commercial Distribution

7011B1

  • Dental composite resin
Renamel® Flowable Microhybrid Body A4, Syringe 3g
DeltaMed GmbH
7011A4
In Commercial Distribution

7011A4

  • Dental composite resin
Renamel® Flowable Microhybrid Body A3, Syringe 3g
DeltaMed GmbH
7011A3
In Commercial Distribution

7011A3

  • Dental composite resin
Renamel® Flowable Microhybrid Body A2, Syringe 3g
DeltaMed GmbH
7011A2
In Commercial Distribution

7011A2

  • Dental composite resin
Renamel® Flowable Microhybrid Body A1, Syringe 3g
DeltaMed GmbH
7011A1
In Commercial Distribution

7011A1

  • Dental composite resin
Renamel® Flowable Microhybrid Body White, Syringe 3g
DeltaMed GmbH
70110W
In Commercial Distribution

70110W

  • Dental composite resin
Renamel® Bulkfill D2, 20 Compules
DeltaMed GmbH
6722D2
In Commercial Distribution

  • EDEL6722D20 ()
  • EDEL6722D21 ()
  • D7796722D21 ()
6722D2

  • Dental composite resin
Renamel® Bulkfill C3, 20 Compules
DeltaMed GmbH
6722C3
In Commercial Distribution

  • EDEL6722C30 ()
  • EDEL6722C31 ()
  • D7796722C31 ()
6722C3

  • Dental composite resin
Renamel® Bulkfill B1, 20 Compules
DeltaMed GmbH
6722B1
In Commercial Distribution

  • EDEL6722B10 ()
  • EDEL6722B11 ()
  • D7796722B11 ()
6722B1

  • Dental composite resin
Renamel® Bulkfill B-Zero, 20 Compules
DeltaMed GmbH
6722B0
In Commercial Distribution

  • EDEL6722B00 ()
  • EDEL6722B01 ()
  • D7796722B01 ()
6722B0

  • Dental composite resin
Renamel® Bulkfill A3, 20 Compules
DeltaMed GmbH
6722A3
In Commercial Distribution

  • EDEL6722A30 ()
  • EDEL6722A31 ()
  • D7796722A31 ()
6722A3

  • Dental composite resin
Renamel® Bulkfill A2, 20 Compules
DeltaMed GmbH
6722A2
In Commercial Distribution

  • EDEL6722A20 ()
  • EDEL6722A21 ()
  • D7796722A21 ()
6722A2

  • Dental composite resin
Renamel® Bulkfill A1, 20 Compules
DeltaMed GmbH
6722A1
In Commercial Distribution

  • EDEL6722A10 ()
  • EDEL6722A11 ()
  • D7796722A11 ()
6722A1

  • Dental composite resin
Renamel® Bulkfill A3.5, 20 Compules
DeltaMed GmbH
672235
In Commercial Distribution

  • EDEL6722350 ()
  • EDEL6722351 ()
  • D7796722351 ()
672235

  • Dental composite resin
Brush & Sculpt™, Syringe 1g
DeltaMed GmbH
627101
In Commercial Distribution

627101

  • Dental composite resin
Insure® UNIVERSAL AutoMix Yellow Red Universal, Syringe 8g
DeltaMed GmbH
625AMU
In Commercial Distribution

  • EDEL625AMU0 ()
625AMU

  • Dental composite resin
Insure® UNIVERSAL AutoMix Yellow Red Light, Syringe 8g
DeltaMed GmbH
625AML
In Commercial Distribution

  • EDEL625AML0 ()
625AML

  • Dental composite resin
Insure® UNIVERSAL AutoMix Clear, Syringe 8g
DeltaMed GmbH
625AMC
In Commercial Distribution

  • EDEL625AMC0 ()
625AMC

  • Dental composite resin
Insure® UNIVERSAL Pink Opaque, Syringe 3g
DeltaMed GmbH
625107
In Commercial Distribution

  • EDEL6251070 ()
625107

  • Dental composite resin
Insure® UNIVERSAL Yellow Opaque, Syringe 3g
DeltaMed GmbH
625106
In Commercial Distribution

  • EDEL6251060 ()
625106

  • Dental composite resin
Insure® UNIVERSAL White Opaque, Syringe 3g
DeltaMed GmbH
625105
In Commercial Distribution

  • EDEL6251050 ()
625105

  • Dental composite resin
Insure® UNIVERSAL Grey Light, Syringe 3g
DeltaMed GmbH
625104
In Commercial Distribution

  • EDEL6251040 ()
625104

  • Dental composite resin
Insure® UNIVERSAL Yellow Red Universal, Syringe 3g
DeltaMed GmbH
625103
In Commercial Distribution

  • EDEL6251030 ()
625103

  • Dental composite resin
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