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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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Enamelize™ - EDEL9061010

Enamelize™, Tube 36g
DeltaMed GmbH
906101
In Commercial Distribution

906101

  • Dentifrice

Renamel® Flowable Microhybrid - EDEL701MWO0

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

701MWO

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL701A350

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

701A35

  • Dental composite resin

Renamel® De-Mark™ - EDEL7011DM0

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

7011DM

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011CO0

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

7011CO

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011C40

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

7011C4

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011C30

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

7011C3

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011C20

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

7011C2

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011B20

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

7011B2

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011A40

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

7011A4

  • Dental composite resin
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