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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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Renamel® Microfill - EDEL6071C10

Renamel® Microfill Enamel Body C1, Syringe 4g
DeltaMed GmbH
6071C1
In Commercial Distribution

6071C1

  • Dental composite resin

Enamelize™ - EDEL9061010

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

906101

  • Dentifrice

Enamelize™ - EDEL9060000

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

906000

  • 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® Flowable Microhybrid - EDEL7011MI0

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

7011MI

  • 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 - EDEL7011D30

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

7011D3

  • 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
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