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 SuperBrite 2, 10 Compules
DeltaMed GmbH
6006S2
In Commercial Distribution

  • EDEL6006S20 ()
  • EDEL6006S21 ()
  • D7796006S21 ()
6006S2

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

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

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

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

  • Dental composite resin
Renamel® NANO™ +plus Light Incisal, 10 Compules
DeltaMed GmbH
6006LI
In Commercial Distribution

  • EDEL6006LI0 ()
  • EDEL6006LI1 ()
  • D7796006LI1 ()
6006LI

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

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

  • Dental composite resin
Renamel® NANO™ +plus Body D2, 10 Compules
DeltaMed GmbH
6006D2
In Commercial Distribution

  • EDEL6006D20 ()
  • EDEL6006D21 ()
  • D7796006D21 ()
6006D2

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

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

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

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

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

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

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

6005LI

  • Dental composite resin
Renamel® NANO™ +plus Body C4, Syringe 5g
DeltaMed GmbH
6005C4
In Commercial Distribution

6005C4

  • Dental composite resin
Renamel® NANO™ +plus Body C3, Syringe 5g
DeltaMed GmbH
6005C3
In Commercial Distribution

6005C3

  • Dental composite resin
Renamel® NANO™ +plus Body C2, Syringe 5g
DeltaMed GmbH
6005C2
In Commercial Distribution

6005C2

  • Dental composite resin
Renamel® NANO™ +plus Body C1, Syringe 5g
DeltaMed GmbH
6005C1
In Commercial Distribution

6005C1

  • Dental composite resin
Renamel® Flowable Microfill Dark Incisal, Syringe 3g
DeltaMed GmbH
3011DI
In Commercial Distribution

3011DI

  • Dental composite resin
Renamel® Flowable Microfill Body D3, Syringe 3g
DeltaMed GmbH
3011D3
In Commercial Distribution

3011D3

  • Dental composite resin
Renamel® Flowable Microfill Body D2, Syringe 3g
DeltaMed GmbH
3011D2
In Commercial Distribution

3011D2

  • Dental composite resin
Renamel® Flowable Microfill Body C5, Syringe 3g
DeltaMed GmbH
3011C5
In Commercial Distribution

3011C5

  • Dental composite resin
Renamel® Flowable Microfill Body C4, Syringe 3g
DeltaMed GmbH
3011C4
In Commercial Distribution

3011C4

  • Dental composite resin
Renamel® Flowable Microfill Body C3, Syringe 3g
DeltaMed GmbH
3011C3
In Commercial Distribution

3011C3

  • Dental composite resin
Renamel® Flowable Microfill Body C2, Syringe 3g
DeltaMed GmbH
3011C2
In Commercial Distribution

3011C2

  • Dental composite resin
Renamel® Flowable Microfill Body C1, Syringe 3g
DeltaMed GmbH
3011C1
In Commercial Distribution

3011C1

  • Dental composite resin
Renamel® Flowable Microfill Body B3, Syringe 3g
DeltaMed GmbH
3011B3
In Commercial Distribution

3011B3

  • Dental composite resin
Renamel® Flowable Microfill Body B1, Syringe 3g
DeltaMed GmbH
3011B1
In Commercial Distribution

3011B1

  • Dental composite resin
Renamel® Flowable Microfill Body A4, Syringe 3g
DeltaMed GmbH
3011A4
In Commercial Distribution

3011A4

  • Dental composite resin
Renamel® Flowable Microfill Body A2, Syringe 3g
DeltaMed GmbH
3011A2
In Commercial Distribution

3011A2

  • Dental composite resin
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 for Veneers or Cast Restorations (Primet). Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

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

  • D801ID6005I1 ()
60-05

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

  • D801ID60051I1 ()
60-05

  • Dentine adhesive
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
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
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
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
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
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
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
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
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
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
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-211
In Commercial Distribution

  • D801ID50211I1 ()
50-211

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-210
In Commercial Distribution

  • D801ID50210I1 ()
50-210

  • Dental composite resin
Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin
DIRECTVIEW CR Cassett with PQ Scrn 15x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978909889 ()
  • 40889978909885 ()
8909889

  • Digital imaging cassette/phosphor plate
DIRECTVIEW CR Cassett with PQ Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978864812 ()
  • 40889978864818 ()
8864811

  • Digital imaging cassette/phosphor plate
DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889978792122 ()
  • 40889978792128 ()
8792129

  • Digital imaging cassette/storage phosphor screen, mammographic
CR SEMI-FIN PLATE PAN 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978666942 ()
  • 40889978666948 ()
8666943

  • Dental computed radiography digital imaging scanner
DIRECTVIEW CR Cassett with PQ Scrn 35x35
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978645442 ()
  • 40889978645448 ()
8645442

  • Digital imaging cassette/phosphor plate
DIRECTVIEW CR Grid Cass w PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
Not in Commercial Distribution

  • 60889978637683 ()
  • 40889978637689 ()
8637688

  • Digital imaging cassette/phosphor plate
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