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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® 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 - EDEL6006B01

Renamel® NANO™ +plus Body B-Zero, 10 Compules
DeltaMed GmbH
6006B0
In Commercial Distribution

  • EDEL6006B00 ()
  • EDEL6006B01 ()
  • D7796006B01 ()
6006B0

  • 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 - EDEL6006A31

Renamel® NANO™ +plus Body A3, 10 Compules
DeltaMed GmbH
6006A3
In Commercial Distribution

  • EDEL6006A30 ()
  • EDEL6006A31 ()
  • D7796006A31 ()
6006A3

  • 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 - EDEL6006A11

Renamel® NANO™ +plus Body A1, 10 Compules
DeltaMed GmbH
6006A1
In Commercial Distribution

  • EDEL6006A10 ()
  • EDEL6006A11 ()
  • D7796006A11 ()
6006A1

  • 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

Insure® Lite - EDEL6051020

Insure® Lite Yellow-Red Light, Syringe 3g
DeltaMed GmbH
605102
In Commercial Distribution

605102

  • Dental composite resin

Insure® Lite - EDEL6051010

Insure® Lite Clear, Syringe 3g
DeltaMed GmbH
605101
In Commercial Distribution

605101

  • Dental composite resin

Prevue® - EDEL6041070

Prevue® Pink Opaque, Syringe 2.5g
DeltaMed GmbH
604107
In Commercial Distribution

604107

  • Dental composite resin

Prevue® - EDEL6041060

Prevue® Yellow Opaque, Syringe 2.5g
DeltaMed GmbH
604106
In Commercial Distribution

604106

  • Dental composite resin

Prevue® - EDEL6041050

Prevue® White Opaque, Syringe 2.5g
DeltaMed GmbH
604105
In Commercial Distribution

604105

  • Dental composite resin

Prevue® - EDEL6041040

Prevue® Grey Light, Syringe 2.5g
DeltaMed GmbH
604104
In Commercial Distribution

604104

  • Dental composite resin

Prevue® - EDEL6041030

Prevue® Yellow-Red Universal, Syringe 2.5g
DeltaMed GmbH
604103
In Commercial Distribution

604103

  • Dental composite resin

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 - EDEL603A350

Creative Color® Opaquer A3.5, Syringe 2.5g
DeltaMed GmbH
603A35
In Commercial Distribution

603A35

  • 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® Pink Opaque™ - EDEL6031PO0

Creative Color® Pink Opaque™, Syringe 2.5g
DeltaMed GmbH
6031PO
In Commercial Distribution

6031PO

  • 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 - EDEL6031HY0

Creative Color® Tint Honey Yellow, Syringe 2.5g
DeltaMed GmbH
6031HY
In Commercial Distribution

6031HY

  • 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 - EDEL6031D30

Creative Color® Opaquer D3-D4, Syringe 2.5g
DeltaMed GmbH
6031D3
In Commercial Distribution

6031D3

  • Dental composite resin

Creative Color® Opaquer - EDEL6031C40

Creative Color® Opaquer C4, Syringe 2.5g
DeltaMed GmbH
6031C4
In Commercial Distribution

6031C4

  • Dental composite resin

Creative Color® Opaquer - EDEL6031C20

Creative Color® Opaquer C2-C3, Syringe 2.5g
DeltaMed GmbH
6031C2
In Commercial Distribution

6031C2

  • Dental composite resin

Creative Color® Opaquer - EDEL6031C10

Creative Color® Opaquer C1-D2, Syringe 2.5g
DeltaMed GmbH
6031C1
In Commercial Distribution

6031C1

  • Dental composite resin

Creative Color® Opaquer - EDEL6031A40

Creative Color® Opaquer A4-A5, Syringe 2.5g
DeltaMed GmbH
6031A4
In Commercial Distribution

6031A4

  • Dental composite resin

Creative Color® Clear Liquid Resin - EDEL6031140

Creative Color® Clear Liquid Resin, Bottle 3g
DeltaMed GmbH
603114
In Commercial Distribution

603114

  • Dental composite resin

Ipana 5% Sodium Fluoride Varnish - Melon - 00060705405333

No Description
MAXILL, INC.
40533
In Commercial Distribution

  • 00060705405333 ()
  • 90060705405336 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Bubble Gum - 00060705405326

No Description
MAXILL, INC.
40532
In Commercial Distribution

  • 00060705405326 ()
  • 90060705405329 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Wintergreen - 00060705405319

No Description
MAXILL, INC.
40531
In Commercial Distribution

  • 00060705405319 ()
  • 90060705405312 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Caramel - 00060705405302

No Description
MAXILL, INC.
40530
In Commercial Distribution

  • 00060705405302 ()
  • 90060705405305 ()


  • Dental cavity varnish

International Dental Supply Fluoroseal Cavity Liner - D801ID75035IZ1

Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Ziploc Bag. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 75-035 IZ
In Commercial Distribution

  • D801ID75035IZ1 ()
75-035

  • Dental cavity varnish

SciPharm CuRay Match Metal Primer - D801ID7010I1

SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

  • Dental composite resin

International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive - D801ID6005I1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-05 I
In Commercial Distribution

  • D801ID6005I1 ()
60-05

  • Dentine adhesive

International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive - D801ID60052I1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive

International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive - D801ID60051I1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-051 I
In Commercial Distribution

  • D801ID60051I1 ()
60-05

  • Dentine adhesive

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50224I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Universal Opaque Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-224 I
In Commercial Distribution

  • D801ID50224I1 ()
50-224

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50222I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Incisal Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-222 I
In Commercial Distribution

  • D801ID50222I1 ()
50-222

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50219I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-219 I
In Commercial Distribution

  • D801ID50219I1 ()
50-219

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50218I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-218 I
In Commercial Distribution

  • D801ID50218I1 ()
50-218

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50217I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-217 I
In Commercial Distribution

  • D801ID50217I1 ()
50-217

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50216I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-216 I
In Commercial Distribution

  • D801ID50216I1 ()
50-216

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50215I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C3/D3Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-215 I
In Commercial Distribution

  • D801ID50215I1 ()
50-215

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50214I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-214 I
In Commercial Distribution

  • D801ID50214I1 ()
50-214

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50213I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A1/B1 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-213 I
In Commercial Distribution

  • D801ID50213I1 ()
50-213

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50212I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3.5 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-212 I
In Commercial Distribution

  • D801ID50212I1 ()
50-212

  • Dental composite resin

AH PLUS JET - D0106670071

AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
667007
In Commercial Distribution

  • D0106670071 ()
  • D0106670070 ()

  • Paste
  • Weight: 15 Gram
667007

  • Endodontic filling/sealing material

AH PLUS JET - D0106670051

AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667005
In Commercial Distribution

  • D0106670051 ()

  • Weight: 15 Gram
  • Paste
667005

  • Endodontic filling/sealing material

AH PLUS ROOTCANAL - D0106670031

AH Plus Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B. With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667003
In Commercial Distribution

  • D0106670031 ()

  • Paste
  • Total Volume: 4 Milliliter
667003

  • Endodontic filling/sealing material
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