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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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Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786021

Aquasil Ultra+ Medium Regular Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678602
In Commercial Distribution

  • D0026786021 ()
  • D0026786020 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678602

  • Silicone dental impression material

Aquasil® Ultra+ Smart Wetting® Impression Material - D0026786011

Aquasil Ultra+ Medium Fast Set 50mL Bulk 24 Pack
DENTSPLY INTERNATIONAL INC.
678601
In Commercial Distribution

  • D0026786011 ()
  • D0026786010 ()

  • Total Volume: 50 Milliliter
  • 24 (50mL) cartridges
678601

  • Silicone dental impression material

Aquasil Ultra LV Fast Set Smart Wetting® Impression Material - D0026784501

Aquasil Ultra LV Fast Set with B4® Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
678450
In Commercial Distribution

  • D00267845082 ()
  • D0026784501 ()
  • D0026784500 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 6 Milliliter
  • 4 cartridges LV FS (50ml), 1 bottle B4 (6ml), 24 Mixing Tips, 24 Intra Oral Tips, 50 Flocked Applicator Tips, 1 Dispensing Well
678450

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material - D0026782761

Aquasil Ultra Heavy FS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678276
In Commercial Distribution

  • D0026782760 ()
  • D0026782761 ()
678276

  • Silicone dental impression material

Aquasil® Ultra Smart Wetting® Impression Material - D0026782751

Aquasil Ultra Heavy RS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678275
In Commercial Distribution

  • D0026782750 ()
  • D0026782751 ()
678275

  • Silicone dental impression material

MM-SEAL - J015206000360

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

  • J015206000360 ()
20600106

  • Endodontic filling/sealing material

Prevue® - EDEL6041020

Prevue® Yellow-Red Light, Syringe 2.5g
DeltaMed GmbH
604102
In Commercial Distribution

604102

  • Dental composite resin

Prevue® - EDEL6041010

Prevue® Clear, Syringe 2.5g
DeltaMed GmbH
604101
In Commercial Distribution

604101

  • Dental composite resin

Creative Color® Opaquer - EDEL6031WO0

Creative Color® Opaquer White, Syringe 2.5g
DeltaMed GmbH
6031WO
In Commercial Distribution

6031WO

  • Dental composite resin

Creative Color® Tint - EDEL6031LB0

Creative Color® Tint Light Brown, Syringe 2.5g
DeltaMed GmbH
6031LB
In Commercial Distribution

6031LB

  • Dental composite resin

Creative Color® Tint - EDEL6031DB0

Creative Color® Tint Dark Brown, Syringe 2.5g
DeltaMed GmbH
6031DB
In Commercial Distribution

6031DB

  • Dental composite resin

Creative Color® Opaquer - EDEL6031A30

Creative Color® Opaquer A3, Syringe 2.5g
DeltaMed GmbH
6031A3
In Commercial Distribution

6031A3

  • Dental composite resin

Creative Color® Opaquer - EDEL6031A10

Creative Color® Opaquer A1-B1-LO, Syringe 2.5g
DeltaMed GmbH
6031A1
In Commercial Distribution

6031A1

  • Dental composite resin

Creative Color® Tint - EDEL60310G0

Creative Color® Tint Grey, Syringe 2.5g
DeltaMed GmbH
60310G
In Commercial Distribution

60310G

  • Dental composite resin

Insure® - EDEL6021080

Insure® Simulcure Catalyst, Syringe 3g
DeltaMed GmbH
602108
In Commercial Distribution

602108

  • Dental composite resin

Insure® - EDEL6021070

Insure® Pink Opaque, Syringe 3g
DeltaMed GmbH
602107
Not in Commercial Distribution

602107

  • Dental composite resin

Insure® - EDEL6021060

Insure® Yellow Opaque, Syringe 3g
DeltaMed GmbH
602106
Not in Commercial Distribution

602106

  • Dental composite resin

Insure® - EDEL6021050

Insure® White Opaque, Syringe 3g
DeltaMed GmbH
602105
In Commercial Distribution

602105

  • Dental composite resin

Insure® - EDEL6021040

Insure® Grey Light, Syringe 3g
DeltaMed GmbH
602104
Not in Commercial Distribution

602104

  • Dental composite resin

Insure® - EDEL6021030

Insure® Yellow-Red Universal, Syringe 3g
DeltaMed GmbH
602103
In Commercial Distribution

602103

  • Dental composite resin

Insure® - EDEL6021020

Insure® Yellow-Red Light, Syringe 3g
DeltaMed GmbH
602102
In Commercial Distribution

602102

  • Dental composite resin

Insure® - EDEL6021010

Insure® Clear, Syringe 3g
DeltaMed GmbH
602101
In Commercial Distribution

602101

  • Dental composite resin

Renamel® Microfill - EDEL601SB30

Renamel® Microfill SuperBrite 3, Syringe 4g
DeltaMed GmbH
601SB3
In Commercial Distribution

601SB3

  • Dental composite resin

Renamel® Microfill - EDEL601SB20

Renamel® Microfill SuperBrite 2, Syringe 4g
DeltaMed GmbH
601SB2
In Commercial Distribution

601SB2

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006WI1

Renamel® NANO™ +plus White Transparent Incisal, 10 Compules
DeltaMed GmbH
6006WI
In Commercial Distribution

  • EDEL6006WI0 ()
  • EDEL6006WI1 ()
  • D7796006WI1 ()
6006WI

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006S11

Renamel® NANO™ +plus SuperBrite 1, 10 Compules
DeltaMed GmbH
6006S1
In Commercial Distribution

  • EDEL6006S10 ()
  • EDEL6006S11 ()
  • D7796006S11 ()
6006S1

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006MI1

Renamel® NANO™ +plus Medium Incisal, 10 Compules
DeltaMed GmbH
6006MI
In Commercial Distribution

  • EDEL6006MI0 ()
  • EDEL6006MI1 ()
  • D7796006MI1 ()
6006MI

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006D31

Renamel® NANO™ +plus Body D3, 10 Compules
DeltaMed GmbH
6006D3
In Commercial Distribution

  • EDEL6006D30 ()
  • EDEL6006D31 ()
  • D7796006D31 ()
6006D3

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006C41

Renamel® NANO™ +plus Body C4, 10 Compules
DeltaMed GmbH
6006C4
In Commercial Distribution

  • EDEL6006C40 ()
  • EDEL6006C41 ()
  • D7796006C41 ()
6006C4

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006C21

Renamel® NANO™ +plus Body C2, 10 Compules
DeltaMed GmbH
6006C2
In Commercial Distribution

  • EDEL6006C20 ()
  • EDEL6006C21 ()
  • D7796006C21 ()
6006C2

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006B21

Renamel® NANO™ +plus Body B2, 10 Compules
DeltaMed GmbH
6006B2
In Commercial Distribution

  • EDEL6006B20 ()
  • EDEL6006B21 ()
  • D7796006B21 ()
6006B2

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006B11

Renamel® NANO™ +plus Body B1, 10 Compules
DeltaMed GmbH
6006B1
In Commercial Distribution

  • EDEL6006B10 ()
  • EDEL6006B11 ()
  • D7796006B11 ()
6006B1

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006A41

Renamel® NANO™ +plus Body A4, 10 Compules
DeltaMed GmbH
6006A4
In Commercial Distribution

  • EDEL6006A40 ()
  • EDEL6006A41 ()
  • D7796006A41 ()
6006A4

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006A21

Renamel® NANO™ +plus Body A2, 10 Compules
DeltaMed GmbH
6006A2
In Commercial Distribution

  • EDEL6006A20 ()
  • EDEL6006A21 ()
  • D7796006A21 ()
6006A2

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6006351

Renamel® NANO™ +plus Body A3.5, 10 Compules
DeltaMed GmbH
600635
In Commercial Distribution

  • EDEL6006350 ()
  • EDEL6006351 ()
  • D7796006351 ()
600635

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6005S30

Renamel® NANO™ +plus SuperBrite 3, Syringe 5g
DeltaMed GmbH
6005S3
In Commercial Distribution

6005S3

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6005S20

Renamel® NANO™ +plus SuperBrite 2, Syringe 5g
DeltaMed GmbH
6005S2
In Commercial Distribution

6005S2

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6005S10

Renamel® NANO™ +plus SuperBrite 1, Syringe 5g
DeltaMed GmbH
6005S1
In Commercial Distribution

6005S1

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6005MI0

Renamel® NANO™ +plus Medium Incisal, Syringe 5g
DeltaMed GmbH
6005MI
In Commercial Distribution

6005MI

  • Dental composite resin

Renamel® NANO™ +plus - EDEL6005LI0

Renamel® NANO™ +plus Light Incisal, Syringe 5g
DeltaMed GmbH
6005LI
In Commercial Distribution

6005LI

  • Dental composite resin
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