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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® Bulkfill - EDEL6722D21

Renamel® Bulkfill D2, 20 Compules
DeltaMed GmbH
6722D2
In Commercial Distribution

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

  • Dental composite resin

Renamel® Bulkfill - EDEL6722B11

Renamel® Bulkfill B1, 20 Compules
DeltaMed GmbH
6722B1
In Commercial Distribution

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

  • Dental composite resin

Renamel® Bulkfill - EDEL6722A31

Renamel® Bulkfill A3, 20 Compules
DeltaMed GmbH
6722A3
In Commercial Distribution

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

  • Dental composite resin

Renamel® Bulkfill - EDEL6722A11

Renamel® Bulkfill A1, 20 Compules
DeltaMed GmbH
6722A1
In Commercial Distribution

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

  • Dental composite resin

Brush & Sculpt™ - EDEL6271010

Brush & Sculpt™, Syringe 1g
DeltaMed GmbH
627101
In Commercial Distribution

627101

  • Dental composite resin

Insure® UNIVERSAL AutoMix - EDEL625AML0

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

  • EDEL625AML0 ()
625AML

  • Dental composite resin

Insure® UNIVERSAL AutoMix - EDEL625AMC0

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

  • EDEL625AMC0 ()
625AMC

  • Dental composite resin

Insure® UNIVERSAL - EDEL6251070

Insure® UNIVERSAL Pink Opaque, Syringe 3g
DeltaMed GmbH
625107
In Commercial Distribution

  • EDEL6251070 ()
625107

  • Dental composite resin

Insure® UNIVERSAL - EDEL6251060

Insure® UNIVERSAL Yellow Opaque, Syringe 3g
DeltaMed GmbH
625106
In Commercial Distribution

  • EDEL6251060 ()
625106

  • Dental composite resin

Insure® UNIVERSAL - EDEL6251040

Insure® UNIVERSAL Grey Light, Syringe 3g
DeltaMed GmbH
625104
In Commercial Distribution

  • EDEL6251040 ()
625104

  • Dental composite resin

Insure® UNIVERSAL - EDEL6251020

Insure® UNIVERSAL Yellow Red Light, Syringe 3g
DeltaMed GmbH
625102
In Commercial Distribution

  • EDEL6251020 ()
625102

  • Dental composite resin

CosmeCore™ - EDEL6227A20

CosmeCore™ A2, Syringe 8g
DeltaMed GmbH
6227A2
In Commercial Distribution

6227A2

  • Dental composite resin

CosmeCore™ - EDEL62270W0

CosmeCore™ White, Syringe 8g
DeltaMed GmbH
62270W
In Commercial Distribution

62270W

  • Dental composite resin

CosmeCore™ - EDEL62210B0

CosmeCore™ Blue, Syringe 50g
DeltaMed GmbH
62210B
In Commercial Distribution

62210B

  • Dental composite resin

COSMESEAL™ Clear - EDEL6170CL0

COSMESEAL® Clear, Syringe 1g
DeltaMed GmbH
6170CL
In Commercial Distribution

6170CL

  • Dental composite resin

Renamel® Microhybrid - EDEL616A350

Renamel® Microhybrid Body A3.5, Syringe 2g
DeltaMed GmbH
616A35
Not in Commercial Distribution

616A35

  • Dental composite resin

Renamel® Microhybrid - EDEL6161D30

Renamel® Microhybrid Body D3, Syringe 2g
DeltaMed GmbH
6161D3
Not in Commercial Distribution

6161D3

  • Dental composite resin

Renamel® Microhybrid - EDEL6161CO0

Renamel® Microhybrid Clear Occlusal, Syringe 2g
DeltaMed GmbH
6161CO
Not in Commercial Distribution

6161CO

  • Dental composite resin

Renamel® Microhybrid - EDEL6161C30

Renamel® Microhybrid Body C3, Syringe 2g
DeltaMed GmbH
6161C3
Not in Commercial Distribution

6161C3

  • Dental composite resin

Renamel® Microhybrid - EDEL6161C20

Renamel® Microhybrid Body C2, Syringe 2g
DeltaMed GmbH
6161C2
Not in Commercial Distribution

6161C2

  • Dental composite resin

Renamel® Microhybrid - EDEL6161B20

Renamel® Microhybrid Body B2, Syringe 2g
DeltaMed GmbH
6161B2
Not in Commercial Distribution

6161B2

  • Dental composite resin

Renamel® Microhybrid - EDEL6161B00

Renamel® Microhybrid Body B-Zero, Syringe 2g
DeltaMed GmbH
6161B0
Not in Commercial Distribution

6161B0

  • Dental composite resin

Renamel® Microhybrid - EDEL6161A20

Renamel® Microhybrid Body A2, Syringe 2g
DeltaMed GmbH
6161A2
Not in Commercial Distribution

6161A2

  • Dental composite resin

Renamel® Microfill - EDEL615SB30

Renamel® Microfill SuperBrite 3, Syringe 2g
DeltaMed GmbH
615SB3
Not in Commercial Distribution

615SB3

  • Dental composite resin

Renamel® Microfill - EDEL615SB10

Renamel® Microfill SuperBrite 1, Syringe 2g
DeltaMed GmbH
615SB1
Not in Commercial Distribution

615SB1

  • Dental composite resin

Renamel® Microfill - EDEL615A350

Renamel® Microfill Enamel Body A3.5, Syringe 2g
DeltaMed GmbH
615A35
Not in Commercial Distribution

615A35

  • Dental composite resin

Renamel® Microfill - EDEL6151MI0

Renamel® Microfill Enamel Medium Incisal, Syringe 2g
DeltaMed GmbH
6151MI
Not in Commercial Distribution

6151MI

  • Dental composite resin

Renamel® Microfill - EDEL6151D30

Renamel® Microfill Enamel Body D3, Syringe 2g
DeltaMed GmbH
6151D3
Not in Commercial Distribution

6151D3

  • Dental composite resin

Renamel® Microfill - EDEL6151C40

Renamel® Microfill Enamel Body C4, Syringe 2g
DeltaMed GmbH
6151C4
Not in Commercial Distribution

6151C4

  • Dental composite resin

Renamel® Microfill - EDEL6151C10

Renamel® Microfill Enamel Body C1, Syringe 2g
DeltaMed GmbH
6151C1
Not in Commercial Distribution

6151C1

  • Dental composite resin
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