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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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Vonflex S Heavy - 08809254455619

Hydrophilic Vinyl Polysiloxane Impression Material; Heavy-bodied consistency; Normal set; 50ml x12 cartridges
VERICOM CO., LTD.
VF360-SHN0
In Commercial Distribution

  • 08809254455619 ()


  • Silicone dental impression material

Auto-Cure Activator - 07290115052886

No Description
B.J.M. LABORATORIES LTD
100060
In Commercial Distribution

  • 07290115052886 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set

Porcelain Etch - 07290115050479

No Description
B.J.M. LABORATORIES LTD
400082
In Commercial Distribution

  • 07290115050479 ()

  • Total Volume: 2.4 Milliliter


  • Dental prosthesis priming agent

Porcelain Silane - 07290115050462

No Description
B.J.M. LABORATORIES LTD
400083
In Commercial Distribution

  • 07290115050462 ()

  • Total Volume: 4 Milliliter


  • Dental prosthesis priming agent

Porcelain Fix - 07290115050448

Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane
B.J.M. LABORATORIES LTD
400084
In Commercial Distribution

  • 07290115050448 ()

  • 2 Syringes 1.2ml (1.3g) Porcelain Etch, 2 Bottles 2ml (1.6g) Porcelain Silane


  • Dental prosthesis priming agent

High-Q-Bond Adhesive Resin Cement Automix - 07290115050370

No Description
B.J.M. LABORATORIES LTD
100050AM
In Commercial Distribution

  • 07290115050370 ()

  • Total Volume: 5 Milliliter


  • Dental composite resin

Multi Bond - 07290115050158

No Description
B.J.M. LABORATORIES LTD
100047
In Commercial Distribution

  • 07290115050158 ()

  • Total Volume: 2 Milliliter


  • Dentine bonding agent/set

Multi Bond - 07290115050141

No Description
B.J.M. LABORATORIES LTD
100046
In Commercial Distribution

  • 07290115050141 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set

E.T.C.™ - 00810000525331

E.T.C.™ Easy Temporary Cement
PARKELL, INC.
S255
In Commercial Distribution

  • 00810000525331 ()
S255

  • Dentine bonding agent/set

MucoHard™ - 00810000525270

MucoHard™ Hard Denture Reline Kit
PARKELL, INC.
S487
Not in Commercial Distribution

  • 00810000525270 ()
S487

  • Denture reliner, hard

MucoHard™ - 00810000525256

MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes
PARKELL, INC.
S485
Not in Commercial Distribution

  • 00810000525256 ()
S485

  • Denture reliner, hard

DuraFinish™ - 00810000525195

All-Cure DuraFinish™ Composite Glaze
PARKELL, INC.
S296
In Commercial Distribution

  • 00810000525195 ()
S296

  • Dental unfilled resin sealant/coating

SNAP™ - 00810000528233

SNAP™ Intro Kit (1-Liquid & 4-Powders) with Russian Labeling (Kraftway)
PARKELL, INC.
S424-R
In Commercial Distribution

  • 00810000528233 ()
S424-R

  • Temporary dental crown/bridge resin

MucoHard™ - 00810000525263

MucoHard™ Resin Refill Cartridge with Tips
PARKELL, INC.
S486
Not in Commercial Distribution

  • 00810000525263 ()
S486

  • Denture reliner, hard

DuraFinish™ - 00810000525188

DuraFinish™ Composite Glaze
PARKELL, INC.
S295
Not in Commercial Distribution

  • 00810000525188 ()
S295

  • Dental unfilled resin sealant/coating

CARDINAL HEALTH - 20885380168557

DISPETTE 2 PLUGGED WESTERGREN
Cardinal Health 200, LLC
B4515-9
In Commercial Distribution

  • 50885380168558 ()
  • 20885380168557 ()
  • 10885380168550 ()
B4515-9

  • Erythrocyte sedimentation rate (ESR) IVD, kit

MucoHard™ - 00810000525690

MucoHard™+ Primer Refill
PARKELL, INC.
S642
In Commercial Distribution

  • 00810000525690 ()
S642

  • Denture reliner, hard

MucoHard™ - 00810000525683

MucoHard™+ Cartridge Refill
PARKELL, INC.
S641
In Commercial Distribution

  • 00810000525683 ()
S641

  • Denture reliner, hard

MucoHard™ - 00810000525676

MucoHard™+ Kit
PARKELL, INC.
S640
In Commercial Distribution

  • 00810000525676 ()
S640

  • Denture reliner, hard

DIRECTVIEW CR Gridded Cassette with PQ Screen - 40889978909885

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 Gridded Cassette with PQ Screen - 40889978864818

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

Imaging Plate - 40889978610095

(2) SZ 3 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978610099 ()
  • 40889978610095 ()
  • 00889978610097 ()
8610099

  • Digital imaging storage phosphor screen

Medical X-ray Blue / MXB Film - 40889978609877

MXB FILM 10X12IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609871 ()
  • 40889978609877 ()
  • 00889978609879 ()
8609877

  • Medical x-ray film, screen

Medical X-ray Blue / MXB Film - 40889978609860

MXB FILM 11X14IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609864 ()
  • 40889978609860 ()
  • 00889978609862 ()
8609869

  • Medical x-ray film, screen

Medical X-ray Blue / MXB Film - 40889978609839

MXB FILM 35X35-14X14 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609833 ()
  • 40889978609839 ()
  • 00889978609831 ()
8609836

  • Medical x-ray film, screen

Medical X-ray Blue / MXB Film - 40889978609815

MXB FILM 35X43-14X17 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609819 ()
  • 40889978609815 ()
  • 00889978609817 ()
8609810

  • Medical x-ray film, screen

CS 7400 - 40889978427969

CR SEMI-FIN PLATE PAN 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978427963 ()
  • 40889978427969 ()
8427965

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Cassette with PQ Screen - 40889978413511

DIRECTVIEW CR Cassett with PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978413515 ()
  • 40889978413511 ()
8413510

  • Digital imaging cassette/phosphor plate

Imaging Plate - 40889978406841

(2) SZ 1 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978406845 ()
  • 40889978406841 ()
  • 00889978406843 ()
8406845

  • Digital imaging storage phosphor screen

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen - 40889971790312

DIRECTVW CR Mammo Cass EHR-M3 Scrn 18X24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889971790316 ()
  • 40889971790312 ()
1790310

  • Digital imaging cassette/storage phosphor screen, mammographic
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